- Email: [email protected]
Accuracy of Published Indications for Predicting Use of Damage Control During Laparotomy for Trauma
j o u r n a l o f s u r g i c a l r e s e a r c h a p r i l 2 0 2 0 ( 2 4 8 ) 4 5 e5 5
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.JournalofSurgicalResearch.com
Accuracy of Published Indications for Predicting Use of Damage Control During Laparotomy for Trauma Derek J. Roberts, MD, PhD,a,* Henry T. Stelfox, MD, PhD,b,c,d Laura J. Moore, MD,e,f Bryan A. Cotton, MD, MPH,e,f John B. Holcomb, MD,e,f and John A. Harvin, MD, MSe,f a
Division of Vascular and Endovascular Surgery, Department of Surgery, Ottawa, Ontario, Canada Department of Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada c Department of Medicine, University of Calgary, Calgary, Alberta, Canada d Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada e Department of Surgery, The University of Texas Health Science Center, Houston, Texas f Center for Translational Injury Research, The University of Texas Health Science Center, Houston, Texas b
article info
abstract
Article history:
Background: Although studies have identified published indications that experts and
Received 24 April 2019
practicing surgeons agree indicate use of damage control (DC) laparotomy, it is unknown
Received in revised form
whether these indications predict use of the procedure in practice.
24 September 2019
Materials and methods: We conducted a diagnostic performance study of the accuracy of a
Accepted 2 November 2019
set of published appropriateness indications for predicting use of DC laparotomy. We
Available online xxx
included consecutive adults that underwent emergent laparotomy for trauma (2011-2016) at Memorial Hermann Hospital.
Keywords:
Results: We included 1141 injured adults. Two published preoperative appropriateness in-
Damage control
dications [a systolic blood pressure (BP) persistently <90 mmHg or core body temperature
Indications
<34 C] produced moderate shifts in the pretest probability of conducting DC instead of
Laparotomy
definitive laparotomy. Five published intraoperative appropriateness indications produced
Wounds and injuries
large and often conclusive changes in the pretest probability of conducting DC during emergent laparotomy. These included the finding of a devascularized or completely disrupted pancreas, duodenum, or pancreaticoduodenal complex; an estimated intraoperative blood loss >4 L; administration of >10 U of packed red blood cells (PRBCs); and a systolic BP persistently <90 mmHg or arterial pH persistently <7.2 during operation. Most indications that produced large changes in the pretest probability of conducting DC laparotomy had an incidence of 2% or less. Conclusions: This study suggests that published appropriateness indications accurately predict use of DC laparotomy in practice. Intraoperative variables exert greater influence on the decision to conduct DC laparotomy than preoperative variables, and those
Work Performed: This work was completed at the Center for Translational Injury Research, The University of Texas Health Science Center, Houston, Texas, United States of America. Meeting Presentation: This work was presented in part at the 76th Annual Meeting of The American Association for the Surgery of Trauma and the Clinical Congress of Acute Care Surgery in Baltimore, Maryland, United States of America on September 15, 2017. * Corresponding author. Division of Vascular and Endovascular Surgery, Department of Surgery, University of Ottawa, The Ottawa Hospital, Civic Campus Room A280, 1053 Carling Avenue, Ottawa, Ontario, Canada K1Y 4E9. Tel.: þ1 403-690-3652. E-mail address: [email protected] (D.J. Roberts). 0022-4804/$ e see front matter ª 2019 Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jss.2019.11.010
46
j o u r n a l o f s u r g i c a l r e s e a r c h a p r i l 2 0 2 0 ( 2 4 8 ) 4 5 e5 5
indications that produce large shifts in the pretest probability of conducting DC laparotomy are uncommonly encountered. ª 2019 Elsevier Inc. All rights reserved.
Introduction In patients undergoing emergent laparotomy for trauma, surgeons must decide whether to perform a damage control (DC) or definitive procedure.1,2 Although many believe that DC laparotomy reduces mortality among those appropriately indicated for the procedure, survivors of the procedure frequently suffer complications (e.g., intraabdominal sepsis, enteric or enteroatmospheric fistula, and complex ventral hernia) and endure long lengths of hospital and intensive care unit (ICU) stay.2-10 Therefore, it is important that DC laparotomy is only performed on patients in which most surgeons agree that the procedure is “appropriate” (i.e., the expected survival benefit of the procedure outweighs the expected risks of its complications).1 In spite of this, several authors have reported data suggesting that wide variation in use of DC laparotomy exists across trauma centers or that DC is presently overused in these centers.10-14 These data are concerning as accumulating evidence suggests that overutilization of DC laparotomy may be associated with increased morbidity and mortality.5,11,12,15-19 For example, one study suggested that the use of DC instead of definitive laparotomy for a variety of indications was associated with a higher propensity score-adjusted incidence of gastrointestinal ileus, abdominal fascial dehiscence, and death.5 We hypothesize that variation in use of DC laparotomy across trauma centers may be partially explained by the uncertainty that exists about whether the benefits of the procedure will outweigh its risks in certain clinical scenarios.1,2 We, therefore, initiated a program of research to develop evidence-informed indications for the appropriate use of DC surgery in civilian trauma patients.1,2,15,16,20 Our work created a list of published pre- and intraoperative clinical scenarios that an international panel of nine trauma surgery experts and a large cohort of practicing surgeons who regularly operate on injured patients in level 1, 2, and 3 trauma centers in one of four different countries consistently agreed appropriately indicated use of DC laparotomy.2,15,16,20 As the above studies described surgeons’ self-reported indications for the use of DC laparotomy, but did not measure how they actually practiced, the surgeons’ assessments of appropriateness may have reflected idealized rather than actual clinical practices.16 In this study, we sought to assess the accuracy of the abovecited appropriateness indications for predicting the use of DC during emergent laparotomy in clinical practice.
for trauma at a level-1, North American trauma center. The study was approved by the institutional review board of the University of Texas Health Science Center at Houston; informed patient consent is waived for this and other types of retrospective study designs. It is reported according to the Standards for Reporting of Diagnostic Accuracy Studies (STARD)21 and STARD for Abstracts.22
Participants and setting We included consecutive adults (16 y of age) that underwent emergent laparotomy for trauma between January 1, 2011, and June 30, 2016 at the Red Duke Trauma Institute at Memorial Hermann HospitaleTexas Medical Center (MHH-TMC). We defined emergent laparotomy as laparotomy performed after transfer of the patient directly from the Emergency Department (ED) to the operating room. MHH-TMC is one of two American College of Surgeons-verified, level-1 trauma centers in Houston, Texas (the fourth largest city in the United States of America), and the primary teaching hospital for the McGovern Medical School (University of Texas Health Science Center at Houston).19
Data source We identified the study cohort from a database maintained by one of the study investigators (JAH), which contains detailed, prospectively collected information on all consecutive patients who underwent emergent laparotomy for trauma at MHH-TMC from January 1, 2011, onward. From this database, we extracted data on operative profile utilized (DC versus definitive); whether one or more published DC appropriateness indications were present in individual study patients; patient demographics; mechanisms of injury; injuries; prehospital vital signs; Emergency Department (ED) rapid thromboelastography (rTEG) results; Abbreviated Injury Scale (AIS) and Injury Severity Scale (ISS) scores; patient vital signs and physiology; and resuscitation fluids administered in the ED and operating room. DC laparotomy was defined as an abbreviated laparotomy, which aimed to control hemorrhage and gross contamination through use of one or more abbreviated (or DC) interventions and that ended with use of an open abdomen.1,2,15 Immediately after presentation, blood and rTEG samples were collected into 2.7 mL Vacutainer (BectoneDickinson, Franklin Lakes, NJ, USA) tubes containing sodium citrate, and then processed using a TEG 5000 Thrombelastograph Hemostasis Analyzer System (Haemonetics Corporation) as previously described.23
Materials and methods Published appropriateness indications Design This is a diagnostic performance study21 of the accuracy of a set of published DC appropriateness indications for predicting use of DC in patients who underwent emergent laparotomy
We examined the accuracy of a list of published DC indications for predicting use of DC during emergent laparotomy for trauma that were rated to be appropriate in two studies previously reported by Roberts et al. These included an
roberts et al accuracy of published dc indications
appropriateness rating study of the indications for DC surgery reported in the peer-reviewed literature, which included nine trauma surgery experts from five different countries,15 and a subsequent cross-sectional survey of the opinions of 201 surgeons practicing in the United States, Canada, Australia, and New Zealand on the appropriateness of these published indications.16 We defined an appropriate indication as a clinical finding, circumstance, or scenario that advised use of DC over definitive laparotomy as the expected survival benefit of the procedure outweighed the expected risks of complications.1,2,15 After removing those indications rated by both experts and the broader practicing surgical community to have uncertain benefit (i.e., a median Likert scale rating of 4-6 in the expert appropriateness rating study15 and 3 in the cross-sectional survey16) or to be inappropriate (i.e., a median Likert scale rating of 1-3 in the expert appropriateness rating study15 and 12 in the cross-sectional survey16), we selected nine preoperative and 13 intraoperative published DC indications that were assessed to be appropriate in the above studies to evaluate their accuracy for predicting use of DC laparotomy in practice (Appendix A). We defined a persistent clinical finding [for example, systolic blood pressure (BP) < 90 mmHg] as one that was present at both the beginning and end of the operation. We also evaluated whether the finding of a traumatic coagulopathy [defined as an (ACT) 128 s, K-time 2.5 min, a-angle 56 , MA 55 mm, or lysis at 30-min (LY-30 3%)24] or hyperfibrinolysis (defined as LY-30 3%25,26) on the presenting ED rTEG was an accurate predictor of the use of DC laparotomy. These were evaluated because the accuracy of these two relatively novel rTEG measures for predicting use of DC is unclear, and coagulopathy has conventionally been considered an appropriate indication for use of DC surgery.1-3,15,16
47
respectively. These statistics were compared using Fisher’s exact and Mann Whitney U-tests, as appropriate. We estimated the cumulative incidence of published preand intraoperative indications.28 We calculated estimates of indication sensitivity, specificity, and positive- and negativeLRs [with surrounding 95% confidence intervals (CIs)] using two-by-two contingency tables. These tables compared the frequency with which an indication was present (the index test) to the frequency with which a patient underwent DC laparotomy (the reference standard). Sensitivity was defined as the percentage of those patients who underwent DC laparotomy that had the published appropriateness indication of interest, while specificity was the proportion of those who did not undergo DC laparotomy and who did not have the indication of interest. The LRs were calculated using the substitution formulae instead of the standard LR calculation method, and 0.5 was added to all cell frequencies before calculation.29 In order to determine the degree to which published appropriateness indications were independently associated with the decision to conduct DC over definitive laparotomy, we used multivariate logistic regression to estimate adjusted odds ratios (ORs) and surrounding 95% confidence intervals (CIs). These adjusted ORs estimated the strength of association between the presence of a pre- or intraoperative published DC appropriateness indication and the conduct of DC laparotomy after adjusting for the presence of other pre- or intraoperative published DC appropriateness indications. We considered two-sided P-values <0.05 significant. Stata MP version 13.1 (Stata Corp., LP, College Station, TX), including the “diagt” module for calculating summary statistics for diagnostic tests, was used for statistical analyses. Missing data [which appeared to be missing completely at random and accounted for 3% (range ¼ 0-14.5%) per variable] of the data included in the data set were handled using pairwise deletion.30
Accuracy Measures of accuracy included sensitivity, specificity, and positive- and negative-likelihood ratios (LRs). The LR in this context indicates by how much the presence of a single published DC appropriateness indication will raise or lower the pretest probability of a patient undergoing DC instead of definitive surgery during emergent laparotomy.27 Using the Journal of the American Medical Association users’ guide for interpreting diagnostic test study results, we considered positive-LRs of 2 to 5 as generating small increases in the preto posttest probability of conducting DC over definitive laparotomy, positive-LRs of 5 to 10 as generating moderate increases, and positive-LRs >10 as generating large and often conclusive increases. Similarly, we considered negative-LRs of 0.5 to 1 as generating small decreases in the pre-to posttest probability of conducting DC over definitive laparotomy, negative-LRs of 0.1 to 0.2 as generating moderate decreases, and negative-LRs of <0.1 as generating large and often conclusive decreases.27
Statistical analyses We summarized categorical and continuous data using counts (percentages) and medians [with interquartile ranges (IQRs)],
Results Participants We included 1141 injured adults who underwent emergent laparotomy for trauma in the study. Their median age was 33 (IQR ¼ 24-47) y, 76% were males, and 56% were injured by blunt mechanisms, resulting in a median abdominal AIS score of 3 (IQR ¼ 2-4) and ISS score of 19 (IQR ¼ 10-32). Moreover, 64% of the patients were severely injured (ISS score 15), 21% had a systolic blood pressure (BP) < 90 mmHg in the trauma bay, 65% received a packed red blood cell (PRBC) transfusion in the preor intraoperative setting, and 31% received a DC laparotomy.
Characteristics of patients who underwent DC versus definitive laparotomy Table 1 displays the baseline characteristics of patients who underwent DC and definitive laparotomy. Those who received DC laparotomy were significantly more frequently injured by blunt mechanisms and had significantly more abdominal solid organ, abdominal vascular, bony pelvis, and extraabdominal injuries. They also had significantly higher median AIS and ISS scores, significantly lower systolic BPs and core
48
j o u r n a l o f s u r g i c a l r e s e a r c h a p r i l 2 0 2 0 ( 2 4 8 ) 4 5 e5 5
Table 1 e Baseline characteristics of the patients by Treatment group.* Characteristic e n (%)
Definitive laparotomy (n ¼ 793)
DC laparotomy (n ¼ 348)
P-value
Demographics Age e median (IQR), y Male gender Penetrating mechanism of injury
32 (23-46)
36 (24-51)
0.01
604 (76)
265 (76)
>0.99
389 (49)
102 (31)
<0.001
249 (31)
144 (41)
0.001
42 (5)
36 (10)
0.003 0.001
Mechanism of injury Motor vehicle collision Motorcycle collision Automobile versus pedestrian
39 (5)
37 (11)
Gunshot wound
216 (27)
101 (29)
0.78
Stab wound
172 (22)
8 (2)
<0.001
75 (10)
22 (6)
NA
Brain
71 (9)
90 (26)
<0.001
Heart
9 (1)
10 (3)
0.04
196 (25)
116 (33)
0.003
Abdominal vascular
82 (10)
90 (26)
<0.001
Small bowel mesentery
213/79227
130 (37)
<0.001
Liver
187 (24)
170 (49)
<0.001
9 (1)
14 (4)
0.002
68 (9)
46 (13)
0.02
Spleen
209 (26)
134 (39)
<0.001
Kidney
80 (10)
85 (24)
<0.001
Urinary bladder or ureter(s)
69 (9)
22 (6)
0.19
Stomach
64 (8)
26 (8)
0.81
Other Injuries
Lung(s)
Extrahepatic bile duct(s)/gallbladder Pancreas
Small bowel
183 (23)
89 (26)
0.37
Colon
180 (23)
97 (28)
0.07
Rectum Pelvic fracture
16 (2)
10 (3)
0.39
106 (13)
102 (29)
<0.001
Severity of injury ISS Score e median (IQR) Head/neck AIS score e median (IQR)
17 (9-26) 0 (0-0)
29 (19-38)
<0.001
0 (0-3)
<0.001
Chest AIS score e median (IQR)
2 (0-3)
3 (0-3)
<0.001
Abdominal AIS score e median (IQR)
3 (2-3)
3 (3-4)
<0.001
2 (0-3)
<0.001
Extremity AIS score e median (IQR) Abdominal AIS score >3
0 (0-2) 166 (21)
169 (49)
<0.001
107 (83-129)
<0.001
Physiology during transport to hospital Systolic BP e median (IQR), mmHg Systolic BP < 90 mmHg
121 (104-140) 69/643 (11)
91/305 (30)
<0.001
Physiology in the trauma bay Systolic BP e median (IQR), mmHg Systolic BP < 90 mmHg GCS score e median (IQR) Temperature e median (IQR), C Base deficit e median (IQR), mmol/L Lactate e median (IQR), mmol/L
120 (105-136) 82/790 (10) 15 (14-15) 36.6 (36.2-36.9)
90 (72-115) 159/345 (46) 13 (3-15) 36.1 (35.7-36.6)
<0.001 <0.001 <0.001 <0.001
3 (0-5)
7 (4-11)
<0.001
2.7 (1.9-4)
5.1 (3.7-7.5)
<0.001
rTEG measures in the trauma bay ACT e median (IQR), sec
113 (105-121)
113 (113-121)
<0.001
K-time e median (IQR), min
1.4 (1.1-1.8)
1.6 (1.2-2)
<0.001
a-angle e median (IQR), deg
74 (70-76)
72 (68-76)
<0.001 (continued)
49
roberts et al accuracy of published dc indications
Table 1 e (continued ) Characteristic e n (%)
Definitive laparotomy (n ¼ 793)
DC laparotomy (n ¼ 348)
P-value
MA e median (IQR), mm
64 (59-68)
62 (56-67)
LY-30 e median (IQR), %
1.5 (0.5-3.1)
1.3 (0.1-3)
<0.001 0.23
rTEG coagulopathy*
403 (51)
203 (58)
0.02
Includes the abdominal aorta and its main tributaries (e.g., superior or inferior mesenteric artery or renal arteries) or the inferior vena cava and its main tributaries (e.g., renal or iliac veins). Where ACT indicates activated clotting time; AIS ¼ Abbreviated Injury Scale; BP ¼ blood pressure; DC ¼ damage control; ED ¼ Emergency Department; FAST ¼ focused assessment with sonography in trauma; FFP ¼ fresh frozen plasma; IQR ¼ interquartile range; ISS ¼ Injury Severity Scale; NA ¼ not applicable; OR ¼ operating room; PRBCs ¼ packed red blood cells; U ¼ units. * Denominator of responses is given if different than stated in column heading.
body temperatures, and significantly higher arterial base deficits (BDs) and lactate levels during transportation to the hospital and in the trauma bay. The Table in Appendix B displays the intraoperative physiology of (at the beginning and end of laparotomy) and resuscitation fluids administered to patients who underwent DC versus definitive laparotomy. Those who underwent DC instead of definitive laparotomy had significantly lower systolic BPs, core body temperatures, and pH values at the beginning and end of trauma laparotomy. Further, patients treated with DC instead of definitive laparotomy received significantly more fresh frozen plasma (FFP), platelets, and PRBCs in both the pre- and intraoperative setting.
Incidence of published appropriateness indications for use of DC laparotomy The incidence of published pre- and intraoperative appropriateness indications among the study cohort ranged from 0.2% to 53% and 0.2% to 71%, respectively (Table 2). The published preoperative appropriateness indications that had the highest incidence among the included patients who underwent emergent laparotomy included an ISS score >25 (36%), a preoperative BD > 15 mmol/L or arterial lactate >5 mmol/L (53%), and the finding of a coagulopathy on the presenting rTEG (53%). The published intraoperative appropriateness indications with the highest incidence included >90 min has already elapsed during the index operation (71%), a systolic BP <90 mmHg at the beginning of operation (15%), administration of >10 U PRBCs across the pre- and intraoperative period (17%), and an arterial pH < 7.2 at the beginning of operation (18%). The published appropriateness indications with the lowest incidence included a successfully resuscitated cardiac arrest during transport to hospital (0.2%); a preoperative core body temperature <34 C (0.9%); the intraoperative finding of a devascularized or completely disrupted pancreas, duodenum, or pancreaticoduodenal complex (0.2%); a temperature <34 C and arterial pH < 7.2 at the beginning of operation (1%); and a systolic BP that was persistently <90 mmHg (1%) or core body temperature that was persistently <34 C (2%) during the operation.
Accuracy of published appropriateness indications for predicting use of DC laparotomy Tables 3 and 4 display the accuracy of published pre- and intraoperative appropriateness indications for predicting use
of DC during emergent laparotomy for trauma, respectively. These indications successfully predicted use of DC in all patients. The presence of six (67%) of the nine published preoperative and 12 (92%) of the 13 published intraoperative appropriateness indications produced a positive shift in the pre-to posttest probability of conducting DC over definitive laparotomy (i.e., both the point estimate of the positive-LR and its 95% CI limits were >1). Two of the published preoperative appropriateness indications [a preoperative systolic BP persistently <90 mmHg (positive-LR ¼ 6.0; 95% CI ¼ 3.8-9.6) and preoperative core body temperature <34 C (positive-LR ¼ 5.4; 95% CI ¼ 1.4-21.2)] produced moderate shifts in the pre-to posttest probability of conducting DC instead of definitive laparotomy (i.e., their positive-LRs were between 5 and 10). The remainder of the published preoperative appropriateness indications for DC laparotomy produced small shifts in the pre-to posttest probability of conducting DC laparotomy (i.e., their positiveLRs were <5). Five of the thirteen published intraoperative appropriate indications produced large and often conclusive changes in the pretest probability of conducting DC during emergent trauma laparotomy (i.e., their positive-LRs were >10). These included the intraoperative finding of a devascularized or completely disrupted pancreas, duodenum, or pancreaticoduodenal complex requiring pancreaticoduodenectomy (positive-LR approaches infinity); an estimated intraoperative blood loss exceeding 4 L (positiveLR ¼ 16.2; 95% CI ¼ 8.5-31.0); the administration of >10 U of PRBCs across the pre- and intraoperative settings; and a systolic BP that was persistently <90 mmHg (positive-LR ¼ 34.2; 95% CI ¼ 4.5-258) or an arterial pH that was persistently <7.2 (positive-LR ¼ 28.9; 95% CI ¼ 9.0-29.0) during emergent laparotomy. The absence of any pre- or intraoperative published appropriateness indication generated small shifts in the preto posttest probability of conducting DC over definitive laparotomy (i.e., all negative-LRs were between 0.45 and 1).
Influence of the presence of other indications on the accuracy of individual indications for predicting use of DC laparotomy Table 5 displays associations between published pre- and intraoperative DC appropriateness indications with the conduct of DC laparotomy before and after adjusting for the simultaneous presence of other published pre- or intraoperative DC appropriateness indications. In these analyses,
50
j o u r n a l o f s u r g i c a l r e s e a r c h a p r i l 2 0 2 0 ( 2 4 8 ) 4 5 e5 5
Table 2 e Incidence of pre- and intraoperative published appropriateness indications across the study period. Indication
n (%) (n ¼ 1141)*
Preoperative indications Information relayed about prehospital trauma patient findings or events The patient suffered a successfully resuscitated cardiac arrest during transport to hospital
2 (0.2)
Trauma patient primary or secondary survey findings The patient presented with a concomitant severe TBI
121/975 (12)
The calculated ISS score of the patient was >25
411 (36)
The patient’s preoperative systolic BP was persistently <90 mmHg
84 (7)
The patient’s preoperative core body temperature was <34 C
9/992 (0.9)
The patient’s preoperative BD was >15 mmol/L or lactate was >5 mmol/L
608/1140 (53)
The patient presented with a coagulopathy on rTEGy
606 (53)
>10 U of PRBCs were given to the patient preoperatively
121 (11)
Intraoperative indications Injury pattern identified during operation The patient is found to have an abdominal vascular injury and a major associated abdominal solid or hollow organ injury The patient is found to have devascularization or disruption of the pancreas, duodenum, or pancreaticoduodenal complex requiring a pancreaticoduodenectomy Multiple blunt or penetrating injuries spanning across more than 1 anatomic region or body cavity that each require surgery
142 (13) 2 (0.2) 72 (6)
Time required for surgery >90 min has already elapsed during the index operation
809 (71)
Estimated blood loss and volume of blood products administered across the pre- and intraoperative settings The patient’s estimated blood loss is > 4 L
81 (7)
>10 U of PRBCs have been given to the patient across the pre- and intraoperative settings
178/1023 (17)
Degree of physiologic insult in the operating room The patient’s systolic BP was <90 mmHg at the beginning of the operation
169/1130 (15)
The patient’s systolic BP was persistently <90 mmHg during the operation
16/1130 (1)
The patient’s core body temperature was <34 C at the beginning of the operation
35/1106 (3)
The patient’s core body temperature was persistently <34 C during the operation
19/1106 (2)
The patient’s arterial pH was <7.2 at the beginning of the operation
207 (18)
The patient’s arterial pH was persistently <7.2 during the operation
41 (4)
The patient’s core body temperature was <34 C and arterial pH < 7.2 at the beginning of the operation
16/1122 (1)
Where BD indicates base deficit; BP ¼ blood pressure; ISS ¼ Injury Severity Scale; PRBC ¼ packed red blood cell; rTEG ¼ rapid thromboelastography; TBI ¼ traumatic brain injury; U ¼ units. * Denominator of patients given if different than stated in the column heading (i.e., in the event of missing data).
although the magnitude of the association between individual indications and the conduct of DC diminished after adjusting for the concomitant presence of other pre- and intraoperative indications, several published appropriateness indications remained independently associated with the conduct of DC during emergent laparotomy. These included patients undergoing emergent laparotomy who presented with a concomitant severe traumatic brain injury (TBI) or calculated ISS score >25; patients whose preoperative systolic BP was persistently <90 mmHg; a preoperative BD > 15 mmol/L or lactate 5 mmol/L; patients who were found to have an abdominal vascular injury and a major associated solid or hollow organ injury or devascularization or complete disruption of the pancreas, duodenum, or pancreaticoduodenal complex requiring pancreaticoduodenectomy; patients whose estimated blood loss was >4 L during operation or who had
received >10 U PRBCs across the pre- and intraoperative settings; and those with an arterial pH that was <7.2 at the beginning of operation.
Discussion In this study, we found that 19 published DC appropriateness indications predicted the use of DC among a cohort of 1141 adults undergoing emergent laparotomy for trauma. While two of the preoperative published appropriateness indications generated moderate shifts, five of the intraoperative published appropriateness indications produced large and frequently conclusive shifts in the pretest probability of conducting DC. Interestingly, many of the published appropriateness indications that produced large shifts in the pretest
51
roberts et al accuracy of published dc indications
Table 3 e Accuracy of published preoperative appropriateness indications for predicting use of damage control laparotomy. Published preoperative appropriateness Indication
Accuracy (95% CI) Sensitivity, %
Specificity, %
Positive-LR
Negative-LR
100 (99-100)
2.1 (0.13-33.8)
1.0 (0.99-1.0)
Information relayed about prehospital trauma patient findings or events The patient suffered a successfully resuscitated cardiac arrest during transport to hospital
0.3 (0.08-2)
Trauma patient primary or secondary survey findings The patient presented with a concomitant severe TBI
28 (23-34)
94 (91-95)
4.3 (3.0-6.0)
0.77 (0.72-0.83)
The calculated ISS score of the patient was >25
61 (55-66)
75 (72-78)
2.4 (2.1-2.8)
0.53 (0.46-0.60)
The patient’s preoperative systolic BP was persistently <90 mmHg
18 (14-22)
97 (96-98)
6.0 (3.8-9.6)
0.85 (0.81-0.89)
2 (0.8-5)
100 (99-100)
5.4 (1.4-21.2)
0.98 (0.96-1.0)
The patient’s preoperative BD was >15 mmol/L or lactate was >5 mmol/L
75 (70-79)
56 (53-60)
1.7 (1.6-1.9)
0.45 (0.37-0.54)
The patient presented with a coagulopathy on rTEG*
58 (53-64)
49 (46-53)
1.2 (1.0-1.3)
0.85 (0.73-0.98)
The patient’s preoperative core body temperature was <34 C
The patient had hyperfibrinolysis on rTEG
40 (35-46)
65 (62-68)
1.2 (0.98-1.4)
0.92 (0.83-1.0)
>10 U of PRBCs were given to the patient preoperatively
13 (10-17)
90 (88-92)
1.4 (0.95-1.9)
0.96 (0.92-1.9)
Where BD indicates base deficit; BP ¼ blood pressure; CI ¼ confidence interval; ISS ¼ Injury Severity Scale; LR ¼ likelihood ratio; PRBC ¼ packed red blood cell; rTEG ¼ rapid thromboelastography; TBI ¼ traumatic brain injury; U ¼ units. * Defined as an activated clotting time 128 s, K-time 2.5 min, a-angle 56 , maximal amplitude 55 mm, or lysis at 30-min 3%.
probability of conducting DC laparotomy had a low incidence among the patients included in this study, suggesting that they are uncommonly encountered in practice. Finally, although the magnitude of the association between individual indications and the conduct of DC diminished after adjusting for the presence of other indications, a small number of published appropriateness indications remained independently associated with the conduct of DC laparotomy. Therefore, many surgeons may choose to conduct DC over definitive laparotomy when they encounter certain single clinical findings (e.g., devascularization or complete disruption of the pancreaticoduodenal complex). Many of the published DC appropriateness indications that produced moderate or large shifts in the pretest probability of conducting DC laparotomy were based on the finding of severely deranged physiology in the pre- or intraoperative setting. These included a systolic BP that was persistently <90 mmHg or a core body temperature <34 C in the trauma bay; a systolic BP that was persistently <90 mmHg or arterial pH that was persistently <7.2 during operation; or a core body temperature that was <34 C and arterial pH that was <7.2 at the beginning of the operation. Further, the presence of a systolic BP that was persistently <90 mmHg or an arterial pH persistently <7.2 during operation produced at least a 3-4 fold larger shift in the pretest probability of undergoing DC laparotomy than the finding of only a single systolic BP <90 mmHg or arterial pH <7.2 at the beginning of operation. These findings suggest that repeated measurements of physiologic variables, such as systolic BP and pH, during the operation significantly influence surgical decision-making. They also support that surgeons may believe that unless physiologic derangements are persistent during an operation, or have already progressed to a point where they are unlikely to improve without truncating the operation (e.g., the finding of severe hypothermia and acidosis at the outset of the
operation), that it is likely often safe to perform a definitive instead of DC laparotomy.16 Authors have historically suggested that patient survival may improve if the decision to perform DC laparotomy is made early before the patient develops significant physiologic derangement.15,16 In this study, the published indications that were potentially independent of the physiology of the patient and altered the pretest probability of conducting DC laparotomy included the identification of three different uncommon to rare injury patterns during the operation. These included an abdominal vascular injury and a major associated abdominal solid or hollow organ injury; devascularization or disruption of the pancreas, duodenum, or pancreaticoduodenal complex; and multiple blunt or penetrating injuries spanning across more than one anatomical region or body cavity that each require surgery. Interestingly, after adjusting for the simultaneous presence of other pre- or intraoperative published DC appropriateness indications, all but the third injury pattern listed above remained independently associated with the conduct of DC during emergent laparotomy. Collectively, the findings of this study have several important implications for understanding surgeons’ decisionmaking regarding operative profile during emergent laparotomy for trauma. They suggest that while preoperative variables influence the probability of whether a patient is selected to undergo DC laparotomy, intraoperative variables frequently exert greater and often more conclusive influence. They also suggest that while some clinical scenarios are independently associated with the decision to conduct DC, the decision to conduct the procedure is often influenced by the simultaneous consideration of several characteristics of the injured patient. These include their physiology, injuries, and/ or amount of blood products or resuscitation fluid they have required or been provided. Finally, many of the published DC appropriateness indications that were shown to produce large
52
j o u r n a l o f s u r g i c a l r e s e a r c h a p r i l 2 0 2 0 ( 2 4 8 ) 4 5 e5 5
Table 4 e Accuracy of published intraoperative appropriateness indications for predicting use of damage control laparotomy. Published intraoperative appropriateness Indication
Accuracy (95% CI) Sensitivity, %
Specificity, %
Positive-LR
Negative-LR
The patient is found to have an abdominal vascular injury and a major associated abdominal solid or hollow organ injury
13 (10-17)
97 (95-98)
3.9 (2.5-6.3)
0.90 (0.86-0.94)
The patient is found to have devascularization or complete disruption of the pancreas, duodenum, or pancreaticoduodenal complex
0.6 (0.07-2)
100 (100-100)
Undefined (approaches infinity)
1.0 (1.0-1.0)
Multiple blunt or penetrating injuries spanning across more than one anatomic region or body cavity that each require surgery
13 (10-17)
97 (95-98)
3.8 (2.4-6.0)
0.90 (0.86-0.94)
62 (57-68)
25 (22-29)
0.84 (0.76-0.92)
1.5 (1.2-1.8)
Injury pattern identified during operation
Time required for surgery >90 min has already elapsed during the index operation
Estimated blood loss and volume of blood products administered across the pre- and intraoperative settings The patient’s estimated blood loss is > 4 L
20 (16-25)
99 (98-99)
16.2 (8.5-31.0)
0.81 (0.76-0.85)
>10 U of PRBCs have been given to the patient across the preand intraoperative settings
47 (41-53)
96 (94-97)
10.5 (7.3-15.0)
0.55 (0.50-0.62)
The patient’s systolic BP was <90 mmHg at the beginning of the operation
29 (25-34)
91 (89-93)
3.4 (2.6-4.5)
0.77 (0.72-0.83)
The patient’s systolic BP was persistently <90 mmHg during the operation
4 (2-7)
100 (99-100)
34.2 (4.5-258)
0.96 (0.94-0.98)
The patient’s core body temperature was <34 C at the beginning of the operation
6 (4-9)
98 (97-99)
3.2 (1.6-6.1)
0.96 (0.93-0.99)
The patient’s core body temperature was persistently <34 C during the operation
3 (2-6)
99 (98-100)
3.3 (1.3-8.0)
0.98 (0.96-1.0)
The patient’s arterial pH was <7.2 at the beginning of the operation
41 (36-47)
91 (89-93)
4.5 (3.5-5.9)
0.64 (0.59-0.71)
The patient’s arterial pH was persistently <7.2 during the operation
11 (8-15)
100 (99-100)
28.9 (9.0-92.9)
0.89 (0.86-0.93)
4 (2-6)
100 (99-100)
7.2 (2.3-22.1)
0.97 (0.95-0.99)
Degree of physiologic insult in the operating room
The patient’s core body temperature was <34 C and arterial pH < 7.2 at the beginning of the operation
Where BP indicates blood pressure; CI ¼ confidence interval; LR ¼ likelihood ratio; PRBC ¼ packed red blood cell; U ¼ units.
changes in the pre-to posttest probability of conducting DC were uncommonly [for example, an abdominal vascular injury and an associated abdominal organ injury (13%)] to rarely [for example, a devascularized or disrupted pancreas, duodenum, or pancreaticoduodenal complex requiring pancreaticoduodenectomy (0.2%)] encountered, even in the setting of a large, level-1 trauma center. This study has a number of limitations. First, it was retrospective, and although we examined the majority of the published appropriateness indications assessed in previous studies, we lacked the data to study the accuracy of all of our previously reported appropriateness indications. Second, this study was conducted at an academic, high-volume, level-1 trauma center in the United States. Therefore, it is possible that surgeons at our center may have different operative and DC practices than surgeons at other centers. It is also possible that our estimates of the incidence of published appropriateness indications and published indication accuracy may not apply to other trauma centers or settings. Third, while the
intraoperative finding of an expanding or difficult to access pelvic hematoma or juxtahepatic venous injury were previously rated to be appropriate indications for use of DC laparotomy in both our expert appropriateness rating study15 and cross-sectional survey of practicing surgeons,16 we did not have the data to evaluate their accuracy for predicting use of DC in this study. Finally, as the ideal rate of use of DC during emergent laparotomy was estimated in one cohort study to range between 19% and 27% across six American, level I trauma centers,31 the frequency of DC laparotomy use in this study (31%) may appear high. However, the rates of use of DC laparotomy across centers in the above-mentioned multicenter cohort study ranged from as low as 16% to as high as 34%.31 Moreover, using a multifaceted quality improvement initiative that included audit and feedback for every DC case, our institution recently decreased the rate of use of DC laparotomy from 39% between 2011 and 2013 to 23% between 2013 and 2015 (a rate that falls within the above ranges of ideal rates of use).19
53
roberts et al accuracy of published dc indications
Table 5 e Unadjusted and adjusted odds of performing damage control laparotomy by published pre- and intraoperative appropriateness indications. Published appropriateness Indication
OR for performing DC over definitive laparotomy (95% CI) Unadjusted
Adjusted*
2.13 (0.13-34.11)
0.60 (0.036-10.17)
Preoperative indications Information relayed about prehospital trauma patient findings or events The patient suffered a successfully resuscitated cardiac arrest during transport to hospital Trauma patient primary or secondary survey findings The patient presented with a concomitant severe TBI
5.51 (3.69-8.22)
1.99 (1.11-3.57)
The calculated ISS score of the patient was >25
4.57 (3.49-5.97)
3.14 (2.06-4.79)
The patient’s preoperative systolic BP was persistently <90 mmHg
7.12 (4.32-11.71)
4.31 (2.09-8.88)
The patient’s preoperative core body temperature was <34 C
5.45 (1.35-21.94)
1.31 (0.19-8.89)
The patient’s preoperative BD was >15 mmol/L or lactate was >5 mmol/L
3.82 (2.89-5.06)
2.90 (1.93-4.35)
The patient presented with a coagulopathy on rTEGy
1.35 (1.05-1.75)
0.97 (0.66-1.43)
>10 U of PRBCs were given to the patient preoperatively
1.40 (0.95-2.07)
1.11 (0.49-2.53)
3.77 (2.62-5.41)
2.78 (1.61-4.82)
Intraoperative indications Injury pattern identified during operation The patient is found to have an abdominal vascular injury and a major associated abdominal solid or hollow organ injury The patient is found to have devascularization or disruption of the pancreas, duodenum, or pancreaticoduodenal complex requiring a pancreaticoduodenectomy Multiple blunt or penetrating injuries spanning across more than 1 anatomic region or body cavity that each require surgery
Perfectly predicted use of DC
Perfectly predicted use of DC
4.21 (2.57-6.91)
1.53 (0.73-3.22)
0.56 (0.43-0.74)
0.37 (0.26-0.53)
Time required for surgery >90 min has already elapsed during the index operation
Estimated blood loss and volume of blood products administered across the pre- and intraoperative settings The patient’s estimated blood loss is > 4 L
20.07 (10.21-39.46)
4.16 (1.60-10.83)
>10 U of PRBCs have been given to the patient across the pre- and intraoperative settings
18.95 (12.46-28.80)
7.84 (4.78-12.86)
4.36 (3.11-6.13)
1.16 (0.71-1.91)
Degree of physiologic insult in the operating room The patient’s systolic BP was <90 mmHg at the beginning of the operation The patient’s systolic BP was persistently <90 mmHg during the operation The patient’s core body temperature was <34 C at the beginning of the operation
35.64 (4.69-270-89) 3.30 (1.67-6.53)
5.01 (0.42-59.72) 2.46 (0.50-12.20)
The patient’s core body temperature was persistently <34 C during the operation
3.34 (1.33-8.39)
0.43 (0.065-2.85)
The patient’s arterial pH was <7.2 at the beginning of the operation
7.03 (5.03-9.83)
2.27 (1.42-3.63)
The patient’s arterial pH was persistently <7.2 during the operation
32.28 (9.89-105.34)
3.26 (0.73-14.50)
7.40 (2.37-23.12)
0.86 (0.11-6.54)
The patient’s core body temperature was <34 C and arterial pH < 7.2 at the beginning of the operation
Where BD indicates base deficit; BP ¼ blood pressure; DC ¼ damage control; ISS ¼ Injury Severity Scale; OR ¼ odds ratio; PRBC ¼ packed red blood cell; rTEG ¼ rapid thromboelastography; TBI ¼ traumatic brain injury; U ¼ units. * Adjusted for the simultaneous presence of other pre- or intraoperative indications in order to determine the independent influence of that individual indication on the decision to conduct DC over definitive laparotomy. y Defined as an activated clotting time 128 s, K-time 2.5 min, a-angle 56 , maximal amplitude 55 mm, or lysis at 30-min 3%.24
Conclusions In this diagnostic performance study, we found that 19 previously published DC appropriateness indications predicted use of DC in 1141 injured adults undergoing emergent laparotomy. Published intraoperative rather than preoperative appropriateness indications exerted greater influence on the pretest probability of conducting DC laparotomy. Further, many of the published appropriateness indications that
produced large shifts in the pretest probability of conducting DC laparotomy were uncommonly encountered in practice. This suggests that absolute indications for the procedure exist, but are uncommon. The published appropriateness indications that were both common and that produced large and often conclusive shifts in the pretest probability of conducting DC laparotomy included an estimated blood loss of >4 L and the administration of >10 U PRBCs. The published appropriateness indications evaluated in this study may be used to educate surgical trainees on the appropriate, limited
54
j o u r n a l o f s u r g i c a l r e s e a r c h a p r i l 2 0 2 0 ( 2 4 8 ) 4 5 e5 5
use of DC laparotomy and to guide trauma center practices until adequately designed studies examining their impact on patient outcomes become available.18,19
Acknowledgment Dr Harvin is supported by a KL2 grant from the Center for Clinical and Translational Sciences, United States, which is funded by National Institutes of Health Clinical and Translational Award UL1 TR000371 and KL2 TR000370 from the National Center for Advancing Translational Sciences, United States. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Advancing Translational Sciences or the National Institutes of Health. Author contributions: Literature search: Roberts. Study concept and design: Roberts. Acquisition of study: Harvin. Data Collection: Harvin. Analysis of data: Roberts and Harvin. Interpretation of data analyses: all authors. Drafting of the manuscript: Roberts. Critical revision of the manuscript: all authors. Study supervision: Harvin.
Disclosure Dr Holcomb is the Chief Medical Officer of Prytime Medical, a founder and on the Board of Directors of Decisio Health, a coinventor of the Junctional Emergency Tourniquet Tool, and serves as an advisor for Terumo BCT, Inc and Arsenal Medical.
Supplementary data Supplementary data to this article can be found online at https://doi.org/10.1016/j.jss.2019.11.010.
references
1. Roberts DJ, Zygun DA, Kirkpatrick AW, et al. A protocol for a scoping and qualitative study to identify and evaluate indications for damage control surgery and damage control interventions in civilian trauma patients. BMJ Open. 2014;4:e005634. 2. Roberts DJ, Bobrovitz N, Zygun DA, et al. Indications for use of damage control surgery and damage control interventions in civilian trauma patients: a scoping review. J Trauma Acute Care Surg. 2015;78:1187e1196. 3. Roberts DJ, Ball CG, Feliciano DV, et al. History of the innovation of damage control for management of trauma patients: 1902-2016. Ann Surg. 2016;265:1034e1044. 4. Shapiro MB, Jenkins DH, Schwab CW, et al. Damage control: collective review. J Trauma. 2000;49:969e978. 5. Harvin JA, Wray CJ, Steward J, et al. Control the damage: morbidity and mortality after emergent trauma laparotomy. Am J Surg. 2016;212:34e39. 6. Brenner M, Bochicchio G, Bochicchio K, et al. Long-term impact of damage control laparotomy: a prospective study. Arch Surg. 2011;146:395e399.
7. Miller RS, Morris Jr JA, Diaz Jr JJ, et al. Complications after 344 damage-control open celiotomies. J Trauma. 2005;59:1365e1371. discussion 1371-4. 8. Dubose JJ, Scalea TM, Holcomb JB, et al. Open abdominal management after damage-control laparotomy for trauma: a prospective observational American Association for the Surgery of Trauma multicenter study. J Trauma Acute Care Surg. 2013;74:113e120. discussion 1120-2. 9. Montalvo JA, Acosta JA, Rodriguez P, et al. Surgical complications and causes of death in trauma patients that require temporary abdominal closure. Am Surg. 2005;71:219e224. 10. Higa G, Friese R, O’Keeffe T, et al. Damage control laparotomy: a vital tool once overused. J Trauma. 2010;69:53e59. 11. Hatch QM, Osterhout LM, Ashraf A, et al. Current use of damage-control laparotomy, closure rates, and predictors of early fascial closure at the first take-back. J Trauma. 2011;70:1429e1436. 12. Martin MJ, Hatch Q, Cotton B, et al. The use of temporary abdominal closure in low-risk trauma patients: helpful or harmful? J Trauma Acute Care Surg. 2012;72:601e606. discussion 606-8. 13. George MJ, Adams SD, McNutt MK, et al. The effect of damage control laparotomy on major abdominal complications: a matched analysis. Am J Surg. 2018;216:56e59. 14. Watson JJ, Nielsen J, Hart K, et al. Damage control laparotomy utilization rates are highly variable among Level I trauma centers: pragmatic, randomized optimal platelet and plasma ratios findings. J Trauma Acute Care Surg. 2017;82:481e488. 15. Roberts DJ, Bobrovitz N, Zygun DA, et al. Indications for use of damage control surgery in civilian trauma patients: a content analysis and expert appropriateness rating study. Ann Surg. 2016;263:1018e1027. 16. Roberts DJ, Zygun DA, Faris PD, et al. Opinions of practicing surgeons on the appropriateness of published indications for use of damage control surgery in trauma patients: an international cross-sectional survey. J Am Coll Surg. 2016;223:515e529. 17. Hatch QM, Osterhout LM, Podbielski J, et al. Impact of closure at the first take back: complication burden and potential overutilization of damage control laparotomy. J Trauma. 2011;71:1503e1511. 18. Roberts DJ. Applications of damage control surgery in modern civilian trauma care. In: Duchesne J, Inaba K, Khan M, eds. Damage Control in Trauma Care: An Evolving Comprehensive Team Approach. Berlin/Heidelberg, Germany: Springer International Publishing; 2018:9e24. 19. Harvin JA, Kao LS, Liang MK, et al. Decreasing the use of damage control laparotomy in trauma: a quality improvement project. J Am Coll Surg. 2017;225:200e209. 20. Roberts DJ, Bobrovitz N, Zygun DA, et al. Indications for use of thoracic, abdominal, pelvic, and vascular damage control interventions in trauma patients: a content analysis and expert appropriateness rating study. J Trauma Acute Care Surg. 2015;79:568e579. 21. Cohen JF, Korevaar DA, Altman DG, et al. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open. 2016;6:e012799. 22. Cohen JF, Korevaar DA, Gatsonis CA, et al. STARD for Abstracts: essential items for reporting diagnostic accuracy studies in journal or conference abstracts. BMJ. 2017;358:j3751. 23. Cotton BA, Faz G, Hatch QM, et al. Rapid thrombelastography delivers real-time results that predict transfusion within 1 hour of admission. J Trauma. 2011;71:407e414. discussion 414-7. 24. Holcomb JB, Minei KM, Scerbo ML, et al. Admission rapid thrombelastography can replace conventional coagulation
roberts et al accuracy of published dc indications
tests in the emergency department: experience with 1974 consecutive trauma patients. Ann Surg. 2012;256:476e486. 25. Cotton BA, Harvin JA, Kostousouv V, et al. Hyperfibrinolysis at admission is an uncommon but highly lethal event associated with shock and prehospital fluid administration. J Trauma Acute Care Surg. 2012;73:365e370. discussion 370. 26. Moore HB, Moore EE, Gonzalez E, et al. Hyperfibrinolysis, physiologic fibrinolysis, and fibrinolysis shutdown: the spectrum of postinjury fibrinolysis and relevance to antifibrinolytic therapy. J Trauma Acute Care Surg. 2014;77:811e817. discussion 817. 27. Jaeschke R, Guyatt G, Sackett DL. Users’ guides to the medical literature. III. How to use an article about a diagnostic test. A. Are the results of the study valid? Evidence-Based Medicine Working Group. JAMA. 1994;271:389e391.
55
28. Scott BN, Roberts DJ, Robertson HL, et al. Incidence, prevalence, and occurrence rate of infection among adults hospitalized after traumatic brain injury: study protocol for a systematic review and meta-analysis. Syst Rev. 2013;2:68. 29. Steed PT. Help for "diagt", "diagti" ((STB-56: sbe36; STB-59: sbe3 6.1): Report summary statistics for diagnostic tests compared to true disease status. Stata help file. 30. Vittinghoff E, Glidden DV, Shiboski SC, et al. Regression Methods in Biostatistics: Linear, Logistic, Survival, and Repeated Measures Models. ed. New York, NY: Springer ScienceþBusiness Media; 2012. 31. Harvin JA, Sharpe JP, Croce MA, et al. Better understanding the utilization of damage control laparotomy: a multiinstitutional quality improvement project. J Trauma Acute Care Surg. 2019;87:27e34.
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.JournalofSurgicalResearch.com
Accuracy of Published Indications for Predicting Use of Damage Control During Laparotomy for Trauma Derek J. Roberts, MD, PhD,a,* Henry T. Stelfox, MD, PhD,b,c,d Laura J. Moore, MD,e,f Bryan A. Cotton, MD, MPH,e,f John B. Holcomb, MD,e,f and John A. Harvin, MD, MSe,f a
Division of Vascular and Endovascular Surgery, Department of Surgery, Ottawa, Ontario, Canada Department of Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada c Department of Medicine, University of Calgary, Calgary, Alberta, Canada d Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada e Department of Surgery, The University of Texas Health Science Center, Houston, Texas f Center for Translational Injury Research, The University of Texas Health Science Center, Houston, Texas b
article info
abstract
Article history:
Background: Although studies have identified published indications that experts and
Received 24 April 2019
practicing surgeons agree indicate use of damage control (DC) laparotomy, it is unknown
Received in revised form
whether these indications predict use of the procedure in practice.
24 September 2019
Materials and methods: We conducted a diagnostic performance study of the accuracy of a
Accepted 2 November 2019
set of published appropriateness indications for predicting use of DC laparotomy. We
Available online xxx
included consecutive adults that underwent emergent laparotomy for trauma (2011-2016) at Memorial Hermann Hospital.
Keywords:
Results: We included 1141 injured adults. Two published preoperative appropriateness in-
Damage control
dications [a systolic blood pressure (BP) persistently <90 mmHg or core body temperature
Indications
<34 C] produced moderate shifts in the pretest probability of conducting DC instead of
Laparotomy
definitive laparotomy. Five published intraoperative appropriateness indications produced
Wounds and injuries
large and often conclusive changes in the pretest probability of conducting DC during emergent laparotomy. These included the finding of a devascularized or completely disrupted pancreas, duodenum, or pancreaticoduodenal complex; an estimated intraoperative blood loss >4 L; administration of >10 U of packed red blood cells (PRBCs); and a systolic BP persistently <90 mmHg or arterial pH persistently <7.2 during operation. Most indications that produced large changes in the pretest probability of conducting DC laparotomy had an incidence of 2% or less. Conclusions: This study suggests that published appropriateness indications accurately predict use of DC laparotomy in practice. Intraoperative variables exert greater influence on the decision to conduct DC laparotomy than preoperative variables, and those
Work Performed: This work was completed at the Center for Translational Injury Research, The University of Texas Health Science Center, Houston, Texas, United States of America. Meeting Presentation: This work was presented in part at the 76th Annual Meeting of The American Association for the Surgery of Trauma and the Clinical Congress of Acute Care Surgery in Baltimore, Maryland, United States of America on September 15, 2017. * Corresponding author. Division of Vascular and Endovascular Surgery, Department of Surgery, University of Ottawa, The Ottawa Hospital, Civic Campus Room A280, 1053 Carling Avenue, Ottawa, Ontario, Canada K1Y 4E9. Tel.: þ1 403-690-3652. E-mail address: [email protected] (D.J. Roberts). 0022-4804/$ e see front matter ª 2019 Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jss.2019.11.010
46
j o u r n a l o f s u r g i c a l r e s e a r c h a p r i l 2 0 2 0 ( 2 4 8 ) 4 5 e5 5
indications that produce large shifts in the pretest probability of conducting DC laparotomy are uncommonly encountered. ª 2019 Elsevier Inc. All rights reserved.
Introduction In patients undergoing emergent laparotomy for trauma, surgeons must decide whether to perform a damage control (DC) or definitive procedure.1,2 Although many believe that DC laparotomy reduces mortality among those appropriately indicated for the procedure, survivors of the procedure frequently suffer complications (e.g., intraabdominal sepsis, enteric or enteroatmospheric fistula, and complex ventral hernia) and endure long lengths of hospital and intensive care unit (ICU) stay.2-10 Therefore, it is important that DC laparotomy is only performed on patients in which most surgeons agree that the procedure is “appropriate” (i.e., the expected survival benefit of the procedure outweighs the expected risks of its complications).1 In spite of this, several authors have reported data suggesting that wide variation in use of DC laparotomy exists across trauma centers or that DC is presently overused in these centers.10-14 These data are concerning as accumulating evidence suggests that overutilization of DC laparotomy may be associated with increased morbidity and mortality.5,11,12,15-19 For example, one study suggested that the use of DC instead of definitive laparotomy for a variety of indications was associated with a higher propensity score-adjusted incidence of gastrointestinal ileus, abdominal fascial dehiscence, and death.5 We hypothesize that variation in use of DC laparotomy across trauma centers may be partially explained by the uncertainty that exists about whether the benefits of the procedure will outweigh its risks in certain clinical scenarios.1,2 We, therefore, initiated a program of research to develop evidence-informed indications for the appropriate use of DC surgery in civilian trauma patients.1,2,15,16,20 Our work created a list of published pre- and intraoperative clinical scenarios that an international panel of nine trauma surgery experts and a large cohort of practicing surgeons who regularly operate on injured patients in level 1, 2, and 3 trauma centers in one of four different countries consistently agreed appropriately indicated use of DC laparotomy.2,15,16,20 As the above studies described surgeons’ self-reported indications for the use of DC laparotomy, but did not measure how they actually practiced, the surgeons’ assessments of appropriateness may have reflected idealized rather than actual clinical practices.16 In this study, we sought to assess the accuracy of the abovecited appropriateness indications for predicting the use of DC during emergent laparotomy in clinical practice.
for trauma at a level-1, North American trauma center. The study was approved by the institutional review board of the University of Texas Health Science Center at Houston; informed patient consent is waived for this and other types of retrospective study designs. It is reported according to the Standards for Reporting of Diagnostic Accuracy Studies (STARD)21 and STARD for Abstracts.22
Participants and setting We included consecutive adults (16 y of age) that underwent emergent laparotomy for trauma between January 1, 2011, and June 30, 2016 at the Red Duke Trauma Institute at Memorial Hermann HospitaleTexas Medical Center (MHH-TMC). We defined emergent laparotomy as laparotomy performed after transfer of the patient directly from the Emergency Department (ED) to the operating room. MHH-TMC is one of two American College of Surgeons-verified, level-1 trauma centers in Houston, Texas (the fourth largest city in the United States of America), and the primary teaching hospital for the McGovern Medical School (University of Texas Health Science Center at Houston).19
Data source We identified the study cohort from a database maintained by one of the study investigators (JAH), which contains detailed, prospectively collected information on all consecutive patients who underwent emergent laparotomy for trauma at MHH-TMC from January 1, 2011, onward. From this database, we extracted data on operative profile utilized (DC versus definitive); whether one or more published DC appropriateness indications were present in individual study patients; patient demographics; mechanisms of injury; injuries; prehospital vital signs; Emergency Department (ED) rapid thromboelastography (rTEG) results; Abbreviated Injury Scale (AIS) and Injury Severity Scale (ISS) scores; patient vital signs and physiology; and resuscitation fluids administered in the ED and operating room. DC laparotomy was defined as an abbreviated laparotomy, which aimed to control hemorrhage and gross contamination through use of one or more abbreviated (or DC) interventions and that ended with use of an open abdomen.1,2,15 Immediately after presentation, blood and rTEG samples were collected into 2.7 mL Vacutainer (BectoneDickinson, Franklin Lakes, NJ, USA) tubes containing sodium citrate, and then processed using a TEG 5000 Thrombelastograph Hemostasis Analyzer System (Haemonetics Corporation) as previously described.23
Materials and methods Published appropriateness indications Design This is a diagnostic performance study21 of the accuracy of a set of published DC appropriateness indications for predicting use of DC in patients who underwent emergent laparotomy
We examined the accuracy of a list of published DC indications for predicting use of DC during emergent laparotomy for trauma that were rated to be appropriate in two studies previously reported by Roberts et al. These included an
roberts et al accuracy of published dc indications
appropriateness rating study of the indications for DC surgery reported in the peer-reviewed literature, which included nine trauma surgery experts from five different countries,15 and a subsequent cross-sectional survey of the opinions of 201 surgeons practicing in the United States, Canada, Australia, and New Zealand on the appropriateness of these published indications.16 We defined an appropriate indication as a clinical finding, circumstance, or scenario that advised use of DC over definitive laparotomy as the expected survival benefit of the procedure outweighed the expected risks of complications.1,2,15 After removing those indications rated by both experts and the broader practicing surgical community to have uncertain benefit (i.e., a median Likert scale rating of 4-6 in the expert appropriateness rating study15 and 3 in the cross-sectional survey16) or to be inappropriate (i.e., a median Likert scale rating of 1-3 in the expert appropriateness rating study15 and 12 in the cross-sectional survey16), we selected nine preoperative and 13 intraoperative published DC indications that were assessed to be appropriate in the above studies to evaluate their accuracy for predicting use of DC laparotomy in practice (Appendix A). We defined a persistent clinical finding [for example, systolic blood pressure (BP) < 90 mmHg] as one that was present at both the beginning and end of the operation. We also evaluated whether the finding of a traumatic coagulopathy [defined as an (ACT) 128 s, K-time 2.5 min, a-angle 56 , MA 55 mm, or lysis at 30-min (LY-30 3%)24] or hyperfibrinolysis (defined as LY-30 3%25,26) on the presenting ED rTEG was an accurate predictor of the use of DC laparotomy. These were evaluated because the accuracy of these two relatively novel rTEG measures for predicting use of DC is unclear, and coagulopathy has conventionally been considered an appropriate indication for use of DC surgery.1-3,15,16
47
respectively. These statistics were compared using Fisher’s exact and Mann Whitney U-tests, as appropriate. We estimated the cumulative incidence of published preand intraoperative indications.28 We calculated estimates of indication sensitivity, specificity, and positive- and negativeLRs [with surrounding 95% confidence intervals (CIs)] using two-by-two contingency tables. These tables compared the frequency with which an indication was present (the index test) to the frequency with which a patient underwent DC laparotomy (the reference standard). Sensitivity was defined as the percentage of those patients who underwent DC laparotomy that had the published appropriateness indication of interest, while specificity was the proportion of those who did not undergo DC laparotomy and who did not have the indication of interest. The LRs were calculated using the substitution formulae instead of the standard LR calculation method, and 0.5 was added to all cell frequencies before calculation.29 In order to determine the degree to which published appropriateness indications were independently associated with the decision to conduct DC over definitive laparotomy, we used multivariate logistic regression to estimate adjusted odds ratios (ORs) and surrounding 95% confidence intervals (CIs). These adjusted ORs estimated the strength of association between the presence of a pre- or intraoperative published DC appropriateness indication and the conduct of DC laparotomy after adjusting for the presence of other pre- or intraoperative published DC appropriateness indications. We considered two-sided P-values <0.05 significant. Stata MP version 13.1 (Stata Corp., LP, College Station, TX), including the “diagt” module for calculating summary statistics for diagnostic tests, was used for statistical analyses. Missing data [which appeared to be missing completely at random and accounted for 3% (range ¼ 0-14.5%) per variable] of the data included in the data set were handled using pairwise deletion.30
Accuracy Measures of accuracy included sensitivity, specificity, and positive- and negative-likelihood ratios (LRs). The LR in this context indicates by how much the presence of a single published DC appropriateness indication will raise or lower the pretest probability of a patient undergoing DC instead of definitive surgery during emergent laparotomy.27 Using the Journal of the American Medical Association users’ guide for interpreting diagnostic test study results, we considered positive-LRs of 2 to 5 as generating small increases in the preto posttest probability of conducting DC over definitive laparotomy, positive-LRs of 5 to 10 as generating moderate increases, and positive-LRs >10 as generating large and often conclusive increases. Similarly, we considered negative-LRs of 0.5 to 1 as generating small decreases in the pre-to posttest probability of conducting DC over definitive laparotomy, negative-LRs of 0.1 to 0.2 as generating moderate decreases, and negative-LRs of <0.1 as generating large and often conclusive decreases.27
Statistical analyses We summarized categorical and continuous data using counts (percentages) and medians [with interquartile ranges (IQRs)],
Results Participants We included 1141 injured adults who underwent emergent laparotomy for trauma in the study. Their median age was 33 (IQR ¼ 24-47) y, 76% were males, and 56% were injured by blunt mechanisms, resulting in a median abdominal AIS score of 3 (IQR ¼ 2-4) and ISS score of 19 (IQR ¼ 10-32). Moreover, 64% of the patients were severely injured (ISS score 15), 21% had a systolic blood pressure (BP) < 90 mmHg in the trauma bay, 65% received a packed red blood cell (PRBC) transfusion in the preor intraoperative setting, and 31% received a DC laparotomy.
Characteristics of patients who underwent DC versus definitive laparotomy Table 1 displays the baseline characteristics of patients who underwent DC and definitive laparotomy. Those who received DC laparotomy were significantly more frequently injured by blunt mechanisms and had significantly more abdominal solid organ, abdominal vascular, bony pelvis, and extraabdominal injuries. They also had significantly higher median AIS and ISS scores, significantly lower systolic BPs and core
48
j o u r n a l o f s u r g i c a l r e s e a r c h a p r i l 2 0 2 0 ( 2 4 8 ) 4 5 e5 5
Table 1 e Baseline characteristics of the patients by Treatment group.* Characteristic e n (%)
Definitive laparotomy (n ¼ 793)
DC laparotomy (n ¼ 348)
P-value
Demographics Age e median (IQR), y Male gender Penetrating mechanism of injury
32 (23-46)
36 (24-51)
0.01
604 (76)
265 (76)
>0.99
389 (49)
102 (31)
<0.001
249 (31)
144 (41)
0.001
42 (5)
36 (10)
0.003 0.001
Mechanism of injury Motor vehicle collision Motorcycle collision Automobile versus pedestrian
39 (5)
37 (11)
Gunshot wound
216 (27)
101 (29)
0.78
Stab wound
172 (22)
8 (2)
<0.001
75 (10)
22 (6)
NA
Brain
71 (9)
90 (26)
<0.001
Heart
9 (1)
10 (3)
0.04
196 (25)
116 (33)
0.003
Abdominal vascular
82 (10)
90 (26)
<0.001
Small bowel mesentery
213/79227
130 (37)
<0.001
Liver
187 (24)
170 (49)
<0.001
9 (1)
14 (4)
0.002
68 (9)
46 (13)
0.02
Spleen
209 (26)
134 (39)
<0.001
Kidney
80 (10)
85 (24)
<0.001
Urinary bladder or ureter(s)
69 (9)
22 (6)
0.19
Stomach
64 (8)
26 (8)
0.81
Other Injuries
Lung(s)
Extrahepatic bile duct(s)/gallbladder Pancreas
Small bowel
183 (23)
89 (26)
0.37
Colon
180 (23)
97 (28)
0.07
Rectum Pelvic fracture
16 (2)
10 (3)
0.39
106 (13)
102 (29)
<0.001
Severity of injury ISS Score e median (IQR) Head/neck AIS score e median (IQR)
17 (9-26) 0 (0-0)
29 (19-38)
<0.001
0 (0-3)
<0.001
Chest AIS score e median (IQR)
2 (0-3)
3 (0-3)
<0.001
Abdominal AIS score e median (IQR)
3 (2-3)
3 (3-4)
<0.001
2 (0-3)
<0.001
Extremity AIS score e median (IQR) Abdominal AIS score >3
0 (0-2) 166 (21)
169 (49)
<0.001
107 (83-129)
<0.001
Physiology during transport to hospital Systolic BP e median (IQR), mmHg Systolic BP < 90 mmHg
121 (104-140) 69/643 (11)
91/305 (30)
<0.001
Physiology in the trauma bay Systolic BP e median (IQR), mmHg Systolic BP < 90 mmHg GCS score e median (IQR) Temperature e median (IQR), C Base deficit e median (IQR), mmol/L Lactate e median (IQR), mmol/L
120 (105-136) 82/790 (10) 15 (14-15) 36.6 (36.2-36.9)
90 (72-115) 159/345 (46) 13 (3-15) 36.1 (35.7-36.6)
<0.001 <0.001 <0.001 <0.001
3 (0-5)
7 (4-11)
<0.001
2.7 (1.9-4)
5.1 (3.7-7.5)
<0.001
rTEG measures in the trauma bay ACT e median (IQR), sec
113 (105-121)
113 (113-121)
<0.001
K-time e median (IQR), min
1.4 (1.1-1.8)
1.6 (1.2-2)
<0.001
a-angle e median (IQR), deg
74 (70-76)
72 (68-76)
<0.001 (continued)
49
roberts et al accuracy of published dc indications
Table 1 e (continued ) Characteristic e n (%)
Definitive laparotomy (n ¼ 793)
DC laparotomy (n ¼ 348)
P-value
MA e median (IQR), mm
64 (59-68)
62 (56-67)
LY-30 e median (IQR), %
1.5 (0.5-3.1)
1.3 (0.1-3)
<0.001 0.23
rTEG coagulopathy*
403 (51)
203 (58)
0.02
Includes the abdominal aorta and its main tributaries (e.g., superior or inferior mesenteric artery or renal arteries) or the inferior vena cava and its main tributaries (e.g., renal or iliac veins). Where ACT indicates activated clotting time; AIS ¼ Abbreviated Injury Scale; BP ¼ blood pressure; DC ¼ damage control; ED ¼ Emergency Department; FAST ¼ focused assessment with sonography in trauma; FFP ¼ fresh frozen plasma; IQR ¼ interquartile range; ISS ¼ Injury Severity Scale; NA ¼ not applicable; OR ¼ operating room; PRBCs ¼ packed red blood cells; U ¼ units. * Denominator of responses is given if different than stated in column heading.
body temperatures, and significantly higher arterial base deficits (BDs) and lactate levels during transportation to the hospital and in the trauma bay. The Table in Appendix B displays the intraoperative physiology of (at the beginning and end of laparotomy) and resuscitation fluids administered to patients who underwent DC versus definitive laparotomy. Those who underwent DC instead of definitive laparotomy had significantly lower systolic BPs, core body temperatures, and pH values at the beginning and end of trauma laparotomy. Further, patients treated with DC instead of definitive laparotomy received significantly more fresh frozen plasma (FFP), platelets, and PRBCs in both the pre- and intraoperative setting.
Incidence of published appropriateness indications for use of DC laparotomy The incidence of published pre- and intraoperative appropriateness indications among the study cohort ranged from 0.2% to 53% and 0.2% to 71%, respectively (Table 2). The published preoperative appropriateness indications that had the highest incidence among the included patients who underwent emergent laparotomy included an ISS score >25 (36%), a preoperative BD > 15 mmol/L or arterial lactate >5 mmol/L (53%), and the finding of a coagulopathy on the presenting rTEG (53%). The published intraoperative appropriateness indications with the highest incidence included >90 min has already elapsed during the index operation (71%), a systolic BP <90 mmHg at the beginning of operation (15%), administration of >10 U PRBCs across the pre- and intraoperative period (17%), and an arterial pH < 7.2 at the beginning of operation (18%). The published appropriateness indications with the lowest incidence included a successfully resuscitated cardiac arrest during transport to hospital (0.2%); a preoperative core body temperature <34 C (0.9%); the intraoperative finding of a devascularized or completely disrupted pancreas, duodenum, or pancreaticoduodenal complex (0.2%); a temperature <34 C and arterial pH < 7.2 at the beginning of operation (1%); and a systolic BP that was persistently <90 mmHg (1%) or core body temperature that was persistently <34 C (2%) during the operation.
Accuracy of published appropriateness indications for predicting use of DC laparotomy Tables 3 and 4 display the accuracy of published pre- and intraoperative appropriateness indications for predicting use
of DC during emergent laparotomy for trauma, respectively. These indications successfully predicted use of DC in all patients. The presence of six (67%) of the nine published preoperative and 12 (92%) of the 13 published intraoperative appropriateness indications produced a positive shift in the pre-to posttest probability of conducting DC over definitive laparotomy (i.e., both the point estimate of the positive-LR and its 95% CI limits were >1). Two of the published preoperative appropriateness indications [a preoperative systolic BP persistently <90 mmHg (positive-LR ¼ 6.0; 95% CI ¼ 3.8-9.6) and preoperative core body temperature <34 C (positive-LR ¼ 5.4; 95% CI ¼ 1.4-21.2)] produced moderate shifts in the pre-to posttest probability of conducting DC instead of definitive laparotomy (i.e., their positive-LRs were between 5 and 10). The remainder of the published preoperative appropriateness indications for DC laparotomy produced small shifts in the pre-to posttest probability of conducting DC laparotomy (i.e., their positiveLRs were <5). Five of the thirteen published intraoperative appropriate indications produced large and often conclusive changes in the pretest probability of conducting DC during emergent trauma laparotomy (i.e., their positive-LRs were >10). These included the intraoperative finding of a devascularized or completely disrupted pancreas, duodenum, or pancreaticoduodenal complex requiring pancreaticoduodenectomy (positive-LR approaches infinity); an estimated intraoperative blood loss exceeding 4 L (positiveLR ¼ 16.2; 95% CI ¼ 8.5-31.0); the administration of >10 U of PRBCs across the pre- and intraoperative settings; and a systolic BP that was persistently <90 mmHg (positive-LR ¼ 34.2; 95% CI ¼ 4.5-258) or an arterial pH that was persistently <7.2 (positive-LR ¼ 28.9; 95% CI ¼ 9.0-29.0) during emergent laparotomy. The absence of any pre- or intraoperative published appropriateness indication generated small shifts in the preto posttest probability of conducting DC over definitive laparotomy (i.e., all negative-LRs were between 0.45 and 1).
Influence of the presence of other indications on the accuracy of individual indications for predicting use of DC laparotomy Table 5 displays associations between published pre- and intraoperative DC appropriateness indications with the conduct of DC laparotomy before and after adjusting for the simultaneous presence of other published pre- or intraoperative DC appropriateness indications. In these analyses,
50
j o u r n a l o f s u r g i c a l r e s e a r c h a p r i l 2 0 2 0 ( 2 4 8 ) 4 5 e5 5
Table 2 e Incidence of pre- and intraoperative published appropriateness indications across the study period. Indication
n (%) (n ¼ 1141)*
Preoperative indications Information relayed about prehospital trauma patient findings or events The patient suffered a successfully resuscitated cardiac arrest during transport to hospital
2 (0.2)
Trauma patient primary or secondary survey findings The patient presented with a concomitant severe TBI
121/975 (12)
The calculated ISS score of the patient was >25
411 (36)
The patient’s preoperative systolic BP was persistently <90 mmHg
84 (7)
The patient’s preoperative core body temperature was <34 C
9/992 (0.9)
The patient’s preoperative BD was >15 mmol/L or lactate was >5 mmol/L
608/1140 (53)
The patient presented with a coagulopathy on rTEGy
606 (53)
>10 U of PRBCs were given to the patient preoperatively
121 (11)
Intraoperative indications Injury pattern identified during operation The patient is found to have an abdominal vascular injury and a major associated abdominal solid or hollow organ injury The patient is found to have devascularization or disruption of the pancreas, duodenum, or pancreaticoduodenal complex requiring a pancreaticoduodenectomy Multiple blunt or penetrating injuries spanning across more than 1 anatomic region or body cavity that each require surgery
142 (13) 2 (0.2) 72 (6)
Time required for surgery >90 min has already elapsed during the index operation
809 (71)
Estimated blood loss and volume of blood products administered across the pre- and intraoperative settings The patient’s estimated blood loss is > 4 L
81 (7)
>10 U of PRBCs have been given to the patient across the pre- and intraoperative settings
178/1023 (17)
Degree of physiologic insult in the operating room The patient’s systolic BP was <90 mmHg at the beginning of the operation
169/1130 (15)
The patient’s systolic BP was persistently <90 mmHg during the operation
16/1130 (1)
The patient’s core body temperature was <34 C at the beginning of the operation
35/1106 (3)
The patient’s core body temperature was persistently <34 C during the operation
19/1106 (2)
The patient’s arterial pH was <7.2 at the beginning of the operation
207 (18)
The patient’s arterial pH was persistently <7.2 during the operation
41 (4)
The patient’s core body temperature was <34 C and arterial pH < 7.2 at the beginning of the operation
16/1122 (1)
Where BD indicates base deficit; BP ¼ blood pressure; ISS ¼ Injury Severity Scale; PRBC ¼ packed red blood cell; rTEG ¼ rapid thromboelastography; TBI ¼ traumatic brain injury; U ¼ units. * Denominator of patients given if different than stated in the column heading (i.e., in the event of missing data).
although the magnitude of the association between individual indications and the conduct of DC diminished after adjusting for the concomitant presence of other pre- and intraoperative indications, several published appropriateness indications remained independently associated with the conduct of DC during emergent laparotomy. These included patients undergoing emergent laparotomy who presented with a concomitant severe traumatic brain injury (TBI) or calculated ISS score >25; patients whose preoperative systolic BP was persistently <90 mmHg; a preoperative BD > 15 mmol/L or lactate 5 mmol/L; patients who were found to have an abdominal vascular injury and a major associated solid or hollow organ injury or devascularization or complete disruption of the pancreas, duodenum, or pancreaticoduodenal complex requiring pancreaticoduodenectomy; patients whose estimated blood loss was >4 L during operation or who had
received >10 U PRBCs across the pre- and intraoperative settings; and those with an arterial pH that was <7.2 at the beginning of operation.
Discussion In this study, we found that 19 published DC appropriateness indications predicted the use of DC among a cohort of 1141 adults undergoing emergent laparotomy for trauma. While two of the preoperative published appropriateness indications generated moderate shifts, five of the intraoperative published appropriateness indications produced large and frequently conclusive shifts in the pretest probability of conducting DC. Interestingly, many of the published appropriateness indications that produced large shifts in the pretest
51
roberts et al accuracy of published dc indications
Table 3 e Accuracy of published preoperative appropriateness indications for predicting use of damage control laparotomy. Published preoperative appropriateness Indication
Accuracy (95% CI) Sensitivity, %
Specificity, %
Positive-LR
Negative-LR
100 (99-100)
2.1 (0.13-33.8)
1.0 (0.99-1.0)
Information relayed about prehospital trauma patient findings or events The patient suffered a successfully resuscitated cardiac arrest during transport to hospital
0.3 (0.08-2)
Trauma patient primary or secondary survey findings The patient presented with a concomitant severe TBI
28 (23-34)
94 (91-95)
4.3 (3.0-6.0)
0.77 (0.72-0.83)
The calculated ISS score of the patient was >25
61 (55-66)
75 (72-78)
2.4 (2.1-2.8)
0.53 (0.46-0.60)
The patient’s preoperative systolic BP was persistently <90 mmHg
18 (14-22)
97 (96-98)
6.0 (3.8-9.6)
0.85 (0.81-0.89)
2 (0.8-5)
100 (99-100)
5.4 (1.4-21.2)
0.98 (0.96-1.0)
The patient’s preoperative BD was >15 mmol/L or lactate was >5 mmol/L
75 (70-79)
56 (53-60)
1.7 (1.6-1.9)
0.45 (0.37-0.54)
The patient presented with a coagulopathy on rTEG*
58 (53-64)
49 (46-53)
1.2 (1.0-1.3)
0.85 (0.73-0.98)
The patient’s preoperative core body temperature was <34 C
The patient had hyperfibrinolysis on rTEG
40 (35-46)
65 (62-68)
1.2 (0.98-1.4)
0.92 (0.83-1.0)
>10 U of PRBCs were given to the patient preoperatively
13 (10-17)
90 (88-92)
1.4 (0.95-1.9)
0.96 (0.92-1.9)
Where BD indicates base deficit; BP ¼ blood pressure; CI ¼ confidence interval; ISS ¼ Injury Severity Scale; LR ¼ likelihood ratio; PRBC ¼ packed red blood cell; rTEG ¼ rapid thromboelastography; TBI ¼ traumatic brain injury; U ¼ units. * Defined as an activated clotting time 128 s, K-time 2.5 min, a-angle 56 , maximal amplitude 55 mm, or lysis at 30-min 3%.
probability of conducting DC laparotomy had a low incidence among the patients included in this study, suggesting that they are uncommonly encountered in practice. Finally, although the magnitude of the association between individual indications and the conduct of DC diminished after adjusting for the presence of other indications, a small number of published appropriateness indications remained independently associated with the conduct of DC laparotomy. Therefore, many surgeons may choose to conduct DC over definitive laparotomy when they encounter certain single clinical findings (e.g., devascularization or complete disruption of the pancreaticoduodenal complex). Many of the published DC appropriateness indications that produced moderate or large shifts in the pretest probability of conducting DC laparotomy were based on the finding of severely deranged physiology in the pre- or intraoperative setting. These included a systolic BP that was persistently <90 mmHg or a core body temperature <34 C in the trauma bay; a systolic BP that was persistently <90 mmHg or arterial pH that was persistently <7.2 during operation; or a core body temperature that was <34 C and arterial pH that was <7.2 at the beginning of the operation. Further, the presence of a systolic BP that was persistently <90 mmHg or an arterial pH persistently <7.2 during operation produced at least a 3-4 fold larger shift in the pretest probability of undergoing DC laparotomy than the finding of only a single systolic BP <90 mmHg or arterial pH <7.2 at the beginning of operation. These findings suggest that repeated measurements of physiologic variables, such as systolic BP and pH, during the operation significantly influence surgical decision-making. They also support that surgeons may believe that unless physiologic derangements are persistent during an operation, or have already progressed to a point where they are unlikely to improve without truncating the operation (e.g., the finding of severe hypothermia and acidosis at the outset of the
operation), that it is likely often safe to perform a definitive instead of DC laparotomy.16 Authors have historically suggested that patient survival may improve if the decision to perform DC laparotomy is made early before the patient develops significant physiologic derangement.15,16 In this study, the published indications that were potentially independent of the physiology of the patient and altered the pretest probability of conducting DC laparotomy included the identification of three different uncommon to rare injury patterns during the operation. These included an abdominal vascular injury and a major associated abdominal solid or hollow organ injury; devascularization or disruption of the pancreas, duodenum, or pancreaticoduodenal complex; and multiple blunt or penetrating injuries spanning across more than one anatomical region or body cavity that each require surgery. Interestingly, after adjusting for the simultaneous presence of other pre- or intraoperative published DC appropriateness indications, all but the third injury pattern listed above remained independently associated with the conduct of DC during emergent laparotomy. Collectively, the findings of this study have several important implications for understanding surgeons’ decisionmaking regarding operative profile during emergent laparotomy for trauma. They suggest that while preoperative variables influence the probability of whether a patient is selected to undergo DC laparotomy, intraoperative variables frequently exert greater and often more conclusive influence. They also suggest that while some clinical scenarios are independently associated with the decision to conduct DC, the decision to conduct the procedure is often influenced by the simultaneous consideration of several characteristics of the injured patient. These include their physiology, injuries, and/ or amount of blood products or resuscitation fluid they have required or been provided. Finally, many of the published DC appropriateness indications that were shown to produce large
52
j o u r n a l o f s u r g i c a l r e s e a r c h a p r i l 2 0 2 0 ( 2 4 8 ) 4 5 e5 5
Table 4 e Accuracy of published intraoperative appropriateness indications for predicting use of damage control laparotomy. Published intraoperative appropriateness Indication
Accuracy (95% CI) Sensitivity, %
Specificity, %
Positive-LR
Negative-LR
The patient is found to have an abdominal vascular injury and a major associated abdominal solid or hollow organ injury
13 (10-17)
97 (95-98)
3.9 (2.5-6.3)
0.90 (0.86-0.94)
The patient is found to have devascularization or complete disruption of the pancreas, duodenum, or pancreaticoduodenal complex
0.6 (0.07-2)
100 (100-100)
Undefined (approaches infinity)
1.0 (1.0-1.0)
Multiple blunt or penetrating injuries spanning across more than one anatomic region or body cavity that each require surgery
13 (10-17)
97 (95-98)
3.8 (2.4-6.0)
0.90 (0.86-0.94)
62 (57-68)
25 (22-29)
0.84 (0.76-0.92)
1.5 (1.2-1.8)
Injury pattern identified during operation
Time required for surgery >90 min has already elapsed during the index operation
Estimated blood loss and volume of blood products administered across the pre- and intraoperative settings The patient’s estimated blood loss is > 4 L
20 (16-25)
99 (98-99)
16.2 (8.5-31.0)
0.81 (0.76-0.85)
>10 U of PRBCs have been given to the patient across the preand intraoperative settings
47 (41-53)
96 (94-97)
10.5 (7.3-15.0)
0.55 (0.50-0.62)
The patient’s systolic BP was <90 mmHg at the beginning of the operation
29 (25-34)
91 (89-93)
3.4 (2.6-4.5)
0.77 (0.72-0.83)
The patient’s systolic BP was persistently <90 mmHg during the operation
4 (2-7)
100 (99-100)
34.2 (4.5-258)
0.96 (0.94-0.98)
The patient’s core body temperature was <34 C at the beginning of the operation
6 (4-9)
98 (97-99)
3.2 (1.6-6.1)
0.96 (0.93-0.99)
The patient’s core body temperature was persistently <34 C during the operation
3 (2-6)
99 (98-100)
3.3 (1.3-8.0)
0.98 (0.96-1.0)
The patient’s arterial pH was <7.2 at the beginning of the operation
41 (36-47)
91 (89-93)
4.5 (3.5-5.9)
0.64 (0.59-0.71)
The patient’s arterial pH was persistently <7.2 during the operation
11 (8-15)
100 (99-100)
28.9 (9.0-92.9)
0.89 (0.86-0.93)
4 (2-6)
100 (99-100)
7.2 (2.3-22.1)
0.97 (0.95-0.99)
Degree of physiologic insult in the operating room
The patient’s core body temperature was <34 C and arterial pH < 7.2 at the beginning of the operation
Where BP indicates blood pressure; CI ¼ confidence interval; LR ¼ likelihood ratio; PRBC ¼ packed red blood cell; U ¼ units.
changes in the pre-to posttest probability of conducting DC were uncommonly [for example, an abdominal vascular injury and an associated abdominal organ injury (13%)] to rarely [for example, a devascularized or disrupted pancreas, duodenum, or pancreaticoduodenal complex requiring pancreaticoduodenectomy (0.2%)] encountered, even in the setting of a large, level-1 trauma center. This study has a number of limitations. First, it was retrospective, and although we examined the majority of the published appropriateness indications assessed in previous studies, we lacked the data to study the accuracy of all of our previously reported appropriateness indications. Second, this study was conducted at an academic, high-volume, level-1 trauma center in the United States. Therefore, it is possible that surgeons at our center may have different operative and DC practices than surgeons at other centers. It is also possible that our estimates of the incidence of published appropriateness indications and published indication accuracy may not apply to other trauma centers or settings. Third, while the
intraoperative finding of an expanding or difficult to access pelvic hematoma or juxtahepatic venous injury were previously rated to be appropriate indications for use of DC laparotomy in both our expert appropriateness rating study15 and cross-sectional survey of practicing surgeons,16 we did not have the data to evaluate their accuracy for predicting use of DC in this study. Finally, as the ideal rate of use of DC during emergent laparotomy was estimated in one cohort study to range between 19% and 27% across six American, level I trauma centers,31 the frequency of DC laparotomy use in this study (31%) may appear high. However, the rates of use of DC laparotomy across centers in the above-mentioned multicenter cohort study ranged from as low as 16% to as high as 34%.31 Moreover, using a multifaceted quality improvement initiative that included audit and feedback for every DC case, our institution recently decreased the rate of use of DC laparotomy from 39% between 2011 and 2013 to 23% between 2013 and 2015 (a rate that falls within the above ranges of ideal rates of use).19
53
roberts et al accuracy of published dc indications
Table 5 e Unadjusted and adjusted odds of performing damage control laparotomy by published pre- and intraoperative appropriateness indications. Published appropriateness Indication
OR for performing DC over definitive laparotomy (95% CI) Unadjusted
Adjusted*
2.13 (0.13-34.11)
0.60 (0.036-10.17)
Preoperative indications Information relayed about prehospital trauma patient findings or events The patient suffered a successfully resuscitated cardiac arrest during transport to hospital Trauma patient primary or secondary survey findings The patient presented with a concomitant severe TBI
5.51 (3.69-8.22)
1.99 (1.11-3.57)
The calculated ISS score of the patient was >25
4.57 (3.49-5.97)
3.14 (2.06-4.79)
The patient’s preoperative systolic BP was persistently <90 mmHg
7.12 (4.32-11.71)
4.31 (2.09-8.88)
The patient’s preoperative core body temperature was <34 C
5.45 (1.35-21.94)
1.31 (0.19-8.89)
The patient’s preoperative BD was >15 mmol/L or lactate was >5 mmol/L
3.82 (2.89-5.06)
2.90 (1.93-4.35)
The patient presented with a coagulopathy on rTEGy
1.35 (1.05-1.75)
0.97 (0.66-1.43)
>10 U of PRBCs were given to the patient preoperatively
1.40 (0.95-2.07)
1.11 (0.49-2.53)
3.77 (2.62-5.41)
2.78 (1.61-4.82)
Intraoperative indications Injury pattern identified during operation The patient is found to have an abdominal vascular injury and a major associated abdominal solid or hollow organ injury The patient is found to have devascularization or disruption of the pancreas, duodenum, or pancreaticoduodenal complex requiring a pancreaticoduodenectomy Multiple blunt or penetrating injuries spanning across more than 1 anatomic region or body cavity that each require surgery
Perfectly predicted use of DC
Perfectly predicted use of DC
4.21 (2.57-6.91)
1.53 (0.73-3.22)
0.56 (0.43-0.74)
0.37 (0.26-0.53)
Time required for surgery >90 min has already elapsed during the index operation
Estimated blood loss and volume of blood products administered across the pre- and intraoperative settings The patient’s estimated blood loss is > 4 L
20.07 (10.21-39.46)
4.16 (1.60-10.83)
>10 U of PRBCs have been given to the patient across the pre- and intraoperative settings
18.95 (12.46-28.80)
7.84 (4.78-12.86)
4.36 (3.11-6.13)
1.16 (0.71-1.91)
Degree of physiologic insult in the operating room The patient’s systolic BP was <90 mmHg at the beginning of the operation The patient’s systolic BP was persistently <90 mmHg during the operation The patient’s core body temperature was <34 C at the beginning of the operation
35.64 (4.69-270-89) 3.30 (1.67-6.53)
5.01 (0.42-59.72) 2.46 (0.50-12.20)
The patient’s core body temperature was persistently <34 C during the operation
3.34 (1.33-8.39)
0.43 (0.065-2.85)
The patient’s arterial pH was <7.2 at the beginning of the operation
7.03 (5.03-9.83)
2.27 (1.42-3.63)
The patient’s arterial pH was persistently <7.2 during the operation
32.28 (9.89-105.34)
3.26 (0.73-14.50)
7.40 (2.37-23.12)
0.86 (0.11-6.54)
The patient’s core body temperature was <34 C and arterial pH < 7.2 at the beginning of the operation
Where BD indicates base deficit; BP ¼ blood pressure; DC ¼ damage control; ISS ¼ Injury Severity Scale; OR ¼ odds ratio; PRBC ¼ packed red blood cell; rTEG ¼ rapid thromboelastography; TBI ¼ traumatic brain injury; U ¼ units. * Adjusted for the simultaneous presence of other pre- or intraoperative indications in order to determine the independent influence of that individual indication on the decision to conduct DC over definitive laparotomy. y Defined as an activated clotting time 128 s, K-time 2.5 min, a-angle 56 , maximal amplitude 55 mm, or lysis at 30-min 3%.24
Conclusions In this diagnostic performance study, we found that 19 previously published DC appropriateness indications predicted use of DC in 1141 injured adults undergoing emergent laparotomy. Published intraoperative rather than preoperative appropriateness indications exerted greater influence on the pretest probability of conducting DC laparotomy. Further, many of the published appropriateness indications that
produced large shifts in the pretest probability of conducting DC laparotomy were uncommonly encountered in practice. This suggests that absolute indications for the procedure exist, but are uncommon. The published appropriateness indications that were both common and that produced large and often conclusive shifts in the pretest probability of conducting DC laparotomy included an estimated blood loss of >4 L and the administration of >10 U PRBCs. The published appropriateness indications evaluated in this study may be used to educate surgical trainees on the appropriate, limited
54
j o u r n a l o f s u r g i c a l r e s e a r c h a p r i l 2 0 2 0 ( 2 4 8 ) 4 5 e5 5
use of DC laparotomy and to guide trauma center practices until adequately designed studies examining their impact on patient outcomes become available.18,19
Acknowledgment Dr Harvin is supported by a KL2 grant from the Center for Clinical and Translational Sciences, United States, which is funded by National Institutes of Health Clinical and Translational Award UL1 TR000371 and KL2 TR000370 from the National Center for Advancing Translational Sciences, United States. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Advancing Translational Sciences or the National Institutes of Health. Author contributions: Literature search: Roberts. Study concept and design: Roberts. Acquisition of study: Harvin. Data Collection: Harvin. Analysis of data: Roberts and Harvin. Interpretation of data analyses: all authors. Drafting of the manuscript: Roberts. Critical revision of the manuscript: all authors. Study supervision: Harvin.
Disclosure Dr Holcomb is the Chief Medical Officer of Prytime Medical, a founder and on the Board of Directors of Decisio Health, a coinventor of the Junctional Emergency Tourniquet Tool, and serves as an advisor for Terumo BCT, Inc and Arsenal Medical.
Supplementary data Supplementary data to this article can be found online at https://doi.org/10.1016/j.jss.2019.11.010.
references
1. Roberts DJ, Zygun DA, Kirkpatrick AW, et al. A protocol for a scoping and qualitative study to identify and evaluate indications for damage control surgery and damage control interventions in civilian trauma patients. BMJ Open. 2014;4:e005634. 2. Roberts DJ, Bobrovitz N, Zygun DA, et al. Indications for use of damage control surgery and damage control interventions in civilian trauma patients: a scoping review. J Trauma Acute Care Surg. 2015;78:1187e1196. 3. Roberts DJ, Ball CG, Feliciano DV, et al. History of the innovation of damage control for management of trauma patients: 1902-2016. Ann Surg. 2016;265:1034e1044. 4. Shapiro MB, Jenkins DH, Schwab CW, et al. Damage control: collective review. J Trauma. 2000;49:969e978. 5. Harvin JA, Wray CJ, Steward J, et al. Control the damage: morbidity and mortality after emergent trauma laparotomy. Am J Surg. 2016;212:34e39. 6. Brenner M, Bochicchio G, Bochicchio K, et al. Long-term impact of damage control laparotomy: a prospective study. Arch Surg. 2011;146:395e399.
7. Miller RS, Morris Jr JA, Diaz Jr JJ, et al. Complications after 344 damage-control open celiotomies. J Trauma. 2005;59:1365e1371. discussion 1371-4. 8. Dubose JJ, Scalea TM, Holcomb JB, et al. Open abdominal management after damage-control laparotomy for trauma: a prospective observational American Association for the Surgery of Trauma multicenter study. J Trauma Acute Care Surg. 2013;74:113e120. discussion 1120-2. 9. Montalvo JA, Acosta JA, Rodriguez P, et al. Surgical complications and causes of death in trauma patients that require temporary abdominal closure. Am Surg. 2005;71:219e224. 10. Higa G, Friese R, O’Keeffe T, et al. Damage control laparotomy: a vital tool once overused. J Trauma. 2010;69:53e59. 11. Hatch QM, Osterhout LM, Ashraf A, et al. Current use of damage-control laparotomy, closure rates, and predictors of early fascial closure at the first take-back. J Trauma. 2011;70:1429e1436. 12. Martin MJ, Hatch Q, Cotton B, et al. The use of temporary abdominal closure in low-risk trauma patients: helpful or harmful? J Trauma Acute Care Surg. 2012;72:601e606. discussion 606-8. 13. George MJ, Adams SD, McNutt MK, et al. The effect of damage control laparotomy on major abdominal complications: a matched analysis. Am J Surg. 2018;216:56e59. 14. Watson JJ, Nielsen J, Hart K, et al. Damage control laparotomy utilization rates are highly variable among Level I trauma centers: pragmatic, randomized optimal platelet and plasma ratios findings. J Trauma Acute Care Surg. 2017;82:481e488. 15. Roberts DJ, Bobrovitz N, Zygun DA, et al. Indications for use of damage control surgery in civilian trauma patients: a content analysis and expert appropriateness rating study. Ann Surg. 2016;263:1018e1027. 16. Roberts DJ, Zygun DA, Faris PD, et al. Opinions of practicing surgeons on the appropriateness of published indications for use of damage control surgery in trauma patients: an international cross-sectional survey. J Am Coll Surg. 2016;223:515e529. 17. Hatch QM, Osterhout LM, Podbielski J, et al. Impact of closure at the first take back: complication burden and potential overutilization of damage control laparotomy. J Trauma. 2011;71:1503e1511. 18. Roberts DJ. Applications of damage control surgery in modern civilian trauma care. In: Duchesne J, Inaba K, Khan M, eds. Damage Control in Trauma Care: An Evolving Comprehensive Team Approach. Berlin/Heidelberg, Germany: Springer International Publishing; 2018:9e24. 19. Harvin JA, Kao LS, Liang MK, et al. Decreasing the use of damage control laparotomy in trauma: a quality improvement project. J Am Coll Surg. 2017;225:200e209. 20. Roberts DJ, Bobrovitz N, Zygun DA, et al. Indications for use of thoracic, abdominal, pelvic, and vascular damage control interventions in trauma patients: a content analysis and expert appropriateness rating study. J Trauma Acute Care Surg. 2015;79:568e579. 21. Cohen JF, Korevaar DA, Altman DG, et al. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open. 2016;6:e012799. 22. Cohen JF, Korevaar DA, Gatsonis CA, et al. STARD for Abstracts: essential items for reporting diagnostic accuracy studies in journal or conference abstracts. BMJ. 2017;358:j3751. 23. Cotton BA, Faz G, Hatch QM, et al. Rapid thrombelastography delivers real-time results that predict transfusion within 1 hour of admission. J Trauma. 2011;71:407e414. discussion 414-7. 24. Holcomb JB, Minei KM, Scerbo ML, et al. Admission rapid thrombelastography can replace conventional coagulation
roberts et al accuracy of published dc indications
tests in the emergency department: experience with 1974 consecutive trauma patients. Ann Surg. 2012;256:476e486. 25. Cotton BA, Harvin JA, Kostousouv V, et al. Hyperfibrinolysis at admission is an uncommon but highly lethal event associated with shock and prehospital fluid administration. J Trauma Acute Care Surg. 2012;73:365e370. discussion 370. 26. Moore HB, Moore EE, Gonzalez E, et al. Hyperfibrinolysis, physiologic fibrinolysis, and fibrinolysis shutdown: the spectrum of postinjury fibrinolysis and relevance to antifibrinolytic therapy. J Trauma Acute Care Surg. 2014;77:811e817. discussion 817. 27. Jaeschke R, Guyatt G, Sackett DL. Users’ guides to the medical literature. III. How to use an article about a diagnostic test. A. Are the results of the study valid? Evidence-Based Medicine Working Group. JAMA. 1994;271:389e391.
55
28. Scott BN, Roberts DJ, Robertson HL, et al. Incidence, prevalence, and occurrence rate of infection among adults hospitalized after traumatic brain injury: study protocol for a systematic review and meta-analysis. Syst Rev. 2013;2:68. 29. Steed PT. Help for "diagt", "diagti" ((STB-56: sbe36; STB-59: sbe3 6.1): Report summary statistics for diagnostic tests compared to true disease status. Stata help file. 30. Vittinghoff E, Glidden DV, Shiboski SC, et al. Regression Methods in Biostatistics: Linear, Logistic, Survival, and Repeated Measures Models. ed. New York, NY: Springer ScienceþBusiness Media; 2012. 31. Harvin JA, Sharpe JP, Croce MA, et al. Better understanding the utilization of damage control laparotomy: a multiinstitutional quality improvement project. J Trauma Acute Care Surg. 2019;87:27e34.