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Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?
YJPSU-58853; No of Pages 6 Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
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Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?☆,☆☆ Nicholas P. McKenna a,b,⁎, Donald D. Potter c, Katherine A. Bews b, Amy E. Glasgow b, Kellie L. Mathis d, Elizabeth B. Habermann a,b a
Department of Surgery, Mayo Clinic, Rochester, MN The Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN Division of Pediatric Surgery, Mayo Clinic, Rochester, MN d Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, MN b c
a r t i c l e
i n f o
Article history: Received 15 September 2018 Accepted 1 October 2018 Available online xxxx Key words: Laparoscopic surgery IPAA NSQIP CUC FAP
a b s t r a c t Purpose: The purpose of this study was to determine if a laparoscopic approach reduces complications and length of stay (LOS) after total proctocolectomy with ileal pouch-anal anastomosis (TPC-IPAA) in pediatric patients using a multicenter prospective database. Methods: The American College of Surgeons National Surgical Quality Improvement Project Pediatric database from 2012 to 2015 was used to identify patients with a diagnosis of chronic ulcerative colitis (CUC) or familial adenomatous polyposis (FAP) undergoing TPC-IPAA. Major complications, minor complications, and prolonged LOS were compared based on laparoscopic versus open approach. Results: 195 (108 female) patients underwent TPC-IPAA at a median age of 14 years (IQR: 11–16) for CUC (N = 99) or FAP (N = 96). Two-thirds of cases were laparoscopic. A laparoscopic approach was not associated with major complications, but lower odds of minor complications were observed. A reduced LOS was seen in laparoscopic versus open surgery (median LOS 6 vs 8 days, p b 0.01). Open IPAA was independently associated with prolonged LOS (N9 days) in the FAP cohort (OR 4.0, 95% CI 1.1–14.0). Conclusion: A laparoscopic approach was not associated with increased major complications but was associated with lower odds of minor complications and shorter LOS. The laparoscopic approach should continue to be preferred for pouch procedures in pediatric patients. Type of study: Treatment; retrospective study. Level of evidence: Level III. © 2018 Elsevier Inc. All rights reserved.
Ileal pouch-anal anastomosis (IPAA) is the surgical treatment of choice for patients with chronic ulcerative colitis (CUC) and familial adenomatous polyposis (FAP) owing to favorable long-term functional outcomes and a high-degree of patient satisfaction [1,2]. However, the short term morbidity associated with IPAA in pediatrics is substantial, ☆ Author Contribution. Study conception and design: Nicholas McKenna, Donald Potter, Kellie Mathis, Elizabeth Habermann. Acquisition of data: Nicholas McKenna, Katherine Bews, Amy Glasgow. Analysis and interpretation of data: Nicholas McKenna, Donald Potter, Katherine Bews, Amy Glasgow, Kellie Mathis, Elizabeth Habermann. Drafting of manuscript: Nicholas McKenna, Donald Potter, Elizabeth Habermann. Critical Revision of manuscript: Nicholas McKenna, Donald Potter, Katherine Bews, Amy Glasgow, Kellie Mathis, Elizabeth Habermann. ☆☆ How this paper will improve care: An analysis of the Pediatric NSQIP database demonstrates that a laparoscopic approach does not increase complications after IPAA and is associated with a decreased length of stay compared to open surgery. A laparoscopic approach should continue to be preferred. ⁎ Corresponding author at: Mayo Clinic, 200 1st St SW, Rochester, MN 55905. Tel.: +1 507 266 6176. E-mail address: [email protected] (N.P. McKenna).
with complication rates ranging from 30% [3] to 60% [4] and postoperative stays commonly exceeding two weeks in length [3,5]. In an effort to curtail length of stay (LOS) and potentially reduce complications, the laparoscopic approach to IPAA has been adopted in pediatric surgery. Studies in adult patients have demonstrated that the laparoscopic approach to IPAA and other colorectal procedures reduces the risk of short-term major and minor complications [6,7]. Laparoscopic surgery also allows earlier feeding [8] and patients have less postoperative analgesic requirements [9]. However, owing to the small sample sizes of single-institution studies, none of the studies examining IPAA in a pediatric population have shown a reduction in short-term complications with the use of a laparoscopic approach, and estimates of its effect on LOS have varied widely [3,5,10]. We believe that a laparoscopic approach does not result in increased major complications and simultaneously decreases the risk of prolonged LOS, but that prior studied did not have large enough samples to demonstrate this. Therefore, the aims of this study were to determine whether a laparoscopic approach reduces the incidence of major
https://doi.org/10.1016/j.jpedsurg.2018.10.005 0022-3468/© 2018 Elsevier Inc. All rights reserved.
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005
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N.P. McKenna et al. / Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
and minor complications after total proctocolectomy with IPAA and to investigate if a laparoscopic approach reduced the risk of a prolonged LOS in pediatric patients using a large, prospectively maintained multicenter database. 1. Methods 1.1. Data source The American College of Surgeons National Surgical Quality Improvement Project (ACS NSQIP) Pediatric data from 2012 to 2015 were utilized. Trained surgical clinical reviewers at each site collect and submit the data from the preoperative period until thirty-days postoperatively. Audits are routinely performed to ensure high quality, accurate data. ACS-NSQIP data are deidentified and exempt from review by the institutional review board at our institution. 1.2. Cohort and outcomes All patients less than 18 years old undergoing a total proctocolectomy with ileal pouch-anal anastomosis (TPC-IPAA: CPT codes: 44157, 44158, and 44211) for CUC (defined by ICD-9556.x or ICD-10K51.xx) or FAP (defined by ICD-9211.3 or ICD-10 D12.1-D12.8) were included. CPT 44157 and 44158 are open approach procedures and CPT 44211 is a laparoscopic approach procedure. Patients undergoing proctectomy only with IPAA were excluded from analysis secondary to the lack of individual laparoscopic and open CPT codes for this procedure. The primary outcome of interest was the occurrence of any major complication. The categorical outcome of any major complication was chosen instead of the total number of major complications owing to the relationship between many of the major complications, for example sepsis and progressive renal insufficiency. Major complications included: deep incisional surgical site infection, wound disruption, organ space infection, pneumonia, unplanned reintubation, progressive renal insufficiency, acute renal failure, blood transfusion, deep venous thrombosis, pulmonary embolism, postoperative sepsis/septic shock, return to the operating room, and death. Secondary outcomes included the occurrence of a minor complication (defined as a superficial surgical site infection [sSSI] or a urinary tract infection [UTI]) and the occurrence of a prolonged LOS. Since 99% of operations were elective, LOS was defined as total hospitalization length, and prolonged LOS was defined as an initial hospitalization longer than the 75th percentile. 1.3. Covariates Patient level variables included sex, race/ethnicity, age, body mass index (underweight: less than the 5th percentile, normal: 5th to 85th percentile, overweight: 85th to 95th percentile, and obese: greater than the 95th percentile) and diagnosis (CUC or FAP). Preoperative comorbidities included history of asthma, biliary/pancreatic/liver disease, and cardiac conditions and preoperative medications included immunosuppressant use or the presence of an immunodeficiency within 30 days of the operation (only available 2012 to July 2015) and steroid use within 30 days of the operation. For the purposes of analyzing major complications, the steroids variable and immunosuppressant variable were combined and grouped into 4 categories: combined therapy, steroids only, immunosuppressant therapy only, and no medications. For the prolonged LOS model in the CUC cohort, medications were grouped as steroids and/or immunosuppressants versus none. Preoperative lab values included hematocrit, white blood cell count, platelet count, and serum albumin. Perioperative and intraoperative variables included ASA class, wound classification, and operative duration. Missing data were excluded from univariate analysis for both categorical and continuous variables, and for multivariable analysis, a missing group was created.
1.4. Statistical analysis Preoperative patient characteristics were compared between those undergoing laparoscopic or open IPAA using χ 2 or Fisher exact test for categorical variables and Wilcoxon rank-sum test and Student t-test for continuous variables. The occurrence of a major complication, of a minor complication, and of prolonged LOS (in the entire cohort as well as in CUC only and FAP only cohorts) was analyzed as a binary outcome on univariate analysis using the previously mentioned tests as appropriate. Multivariable logistic regression was then conducted for the occurrence of major complications, prolonged LOS in the entire cohort, and prolonged LOS in the CUC and FAP cohorts individually. Additionally, a multivariable analysis was performed only for patients in the overall cohort and CUC cohorts who had surgery on hospital day 0 or 1 to determine if total hospital stay was skewed by patients admitted for extended periods preoperatively. All patients in the FAP cohort had surgery on hospital day 0 or 1. Multivariable analysis was not performed on the occurrence of a minor complication secondary to a limited number of events. Covariates significant on univariate analysis or deemed clinically relevant (wound classification, preoperative steroid/immunosuppressant use) were chosen for inclusion in the major complications model and the prolonged LOS models. Statistical analysis was performed using SAS 9.4 software (SAS Institute, Cary, NC) with significance set at p b 0.05. 2. Results 2.1. Clinical characteristics and operative characteristics 195 (55% female) patients underwent TPC-IPAA at a median age of 14 years (IQR: 11–16) for CUC (N = 99) or FAP (N = 96). Two-thirds of cases (N = 132) were performed laparoscopically. The two groups did not differ on preoperative clinical characteristics, though an increased percentage of obese children underwent open IPAA. Operative time did not differ between the laparoscopic and open group (Table 1). 2.2. Major and minor complications There were a total of 63 major complications in 43 patients. A laparoscopic approach did not reach significance on univariate analysis of having a major complication, but preoperative leukocytosis and preoperative systemic inflammatory response (SIRS) did (both p b 0.05). A multivariable model for sustaining a major complication was built with leukocytosis, wound classification, and steroid/immunosuppressant use included. A wound classification of contaminated or dirty/infected versus clean or clean–contaminated was a significant predictor of having a major complication (odds ratio: 2.7, 95% CI 1.1–6.6). Preoperative combination immunosuppression with a steroid and an immunosuppressant and preoperative leukocytosis did not reach significance for having a major complication. Full results from the univariate and multivariable are available in Tables 2 and 3. There were 12 minor complications in 12 patients. A laparoscopic approach was associated with a lower rate of minor complications (p = 0.02) on univariate analysis as compared to open surgery. Obesity and preoperative immunosuppressant use were also associated with the occurrence of a minor complication (both p b 0.05). 2.3. Length of stay Median LOS was 7 days (interquartile range [IQR] 5–9) in those without a major complication prior to discharge, and it increased to 13.5 days (IQR 8–19) in patients with a major complication prior to discharge. A laparoscopic approach was associated with a decreased LOS compared to open surgery (median [IQR]: 7 [5–9] vs 9 [6–12] days, p b 0.01) in all patients, as well as a decreased LOS in those without a
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005
N.P. McKenna et al. / Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
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Table 1 Preoperative clinical characteristics and operative characteristics of entire cohort. Clinical Characteristics Agea Race/Ethnicity Non-Hispanic White Hispanic White Black/African American Asian Other/Unknown Sex Male Female Diagnosis CUC FAP Body Mass Index Missing Underweight Normal Overweight Obese History of asthma Biliary/Liver/Pancreatic Disease Cardiac Risk Factors Steroids Immunosuppressants/Immunodeficiency Weight loss or failure to thrive Preoperative SIRS Preoperative hematocrita Preoperative white blood cell counta Preoperative platelet counta Preoperative albumina Operative Characteristics ASA class I–II III Case status Elective Urgent Wound Class Clean Clean/Contaminated Contaminated Dirty/Infected Operative Time, min b242 243–322 323–408 409–761 Days from operation to dischargea a
Total Cohort (n = 195) 14 (11–16)
Laparoscopic Group (n = 132) 14 (11.5–16)
Open Group (n = 63) 14 (10–16)
148 (75.9) 16 (8.2) 22 (11.3) 1 (0.5) 8 (4.1)
101 (76.5) 12 (9.1) 15 (11.4) 1 (0.8) 3 (2.3)
47 (74.6) 4 (6.3) 7 (11.1) 0 (0.0) 5 (7.9)
87 (44.6) 108 (55.4)
60 (45.5) 72 (54.5)
27 (42.9) 36 (57.1)
99 (50.8) 96 (49.2)
65 (49.2) 67 (50.8)
34 (54.0) 29 (46.0)
p-value 0.65 0.39
0.76
0.54
0.10 12 10 (5.5) 114 (62.3) 32 (17.5) 27 (14.8) 13 (6.7) 10 (5.9) 1 (0.5) 33 (16.9) 18 (10.7) 5 (3.6) 4 (2.1) 37.0 (34.0–40.3) 7.4 (5.8–9.7) 309 (258–363) 4.0 (3.5–4.4)
7 8 (6.4) 77 (61.6) 26 (20.8) 14 (11.2) 8 (6.1) 6 (5.1) 1 (0.8) 23 (17.4) 13 (11.1) 4 (4.3) 3 (2.3) 37.1 (34.9–40.0) 7.4 (6.2–10.2) 320 (260–363) 4.0 (3.7–4.5)
5 2 (3.4) 37 (63.8) 6 (10.3) 13 (22.4) 5 (7.9) 4 (7.7) 0 (0.0) 10 (15.9) 5 (9.6) 1 (2.2) 1 (1.6) 37.0 (33.8–40.3) 7.2 (5.2–9.5) 287 (252–363) 4.0 (2.8–4.3)
0.76 0.50 1.0 0.84 1.0 1.0 1.0 0.87 0.48 0.20 0.44 0.61
143 (73.3) 52 (26.7)
95 (72.0) 37 (28.0)
48 (76.2) 15 (23.8)
193 (99.0) 2 (1.0)
131 (99.2) 1 (0.8)
62 (98.4) 1 (1.6)
3 (1.5) 161 (82.6) 24 (12.3) 7 (3.6)
3 (2.3) 109 (82.6) 15 (11.4) 5 (3.8)
0 (0.0) 52 (82.5) 9 (14.3) 2 (3.2)
48 (24.6) 50 (25.6) 48 (24.6) 49 (25.1) 7 (5–9)
28 (21.2) 36 (27.3) 34 (25.8) 34 (25.8) 6 (5–9)
20 (31.7) 14 (22.2) 14 (22.2) 15 (23.8) 8 (6–10)
0.54
0.77
0.48
b0.01
Data expressed as median and interquartile range; otherwise expressed as number and percent.
major complication prior to discharge (median [IQR]: 6 [5–8] vs 8 [6–10] days, p b 0.01). Univariate analysis of risk factors for prolonged LOS in the entire group revealed race/ethnicity, laparoscopic surgery, wound classification, a major complication prior to discharge, and a minor complication prior to discharge to be significant (all p b 0.05). In the CUC cohort, factors associated with prolonged LOS included race/ethnicity and having a major complication prior to discharge (both p b 0.05), and in the FAP cohort a history of asthma and having a major complication prior to discharge were significantly associated with prolonged LOS (both p b 0.05). On multivariable analysis, open surgery was associated with prolonged LOS in the FAP cohort, but did not reach significance in the overall cohort or CUC cohort. A major complication prior to discharge was an independent risk factor for prolonged LOS in all models. Full multivariable results are presented in Table 4. Multivariable analysis of just the patients operated on within 1 day of admission in the overall cohort along with CUC cohort revealed similar results with respect to the impact of open surgery and odds of prolonged length of stay (overall, odds ratio [95% confidence interval]: 1.85 [0.8–4.6]; CUC, 1.63 [0.4–6.2]).
3. Discussion While the laparoscopic approach to IPAA is preferred in adults owing to decreased postoperative pain, earlier return of bowel function, and decreased LOS, similar findings have not been demonstrated in pediatric patients. Using a large, multicenter database, we found no increase in major complications, a decreased rate of minor complications, and a reduced LOS with the use of a laparoscopic approach to total proctocolectomy with IPAA. These results support the continued performance of a laparoscopic total proctocolectomy with IPAA to all pediatric patients when clinically indicated. The 22% rate of experiencing one or more major complications in this study is comparable to smaller, single-center studies in pediatric patients [3,5]. Owing to small sample sizes in other pediatric studies on IPAA, a multivariable model of risk factors for major complications has not been built previously. We were able to develop the first multivariable model for major complications after pediatric IPAA, and the only independent risk factor identified was a wound classification of contaminated or dirty/infected. Contaminated and dirty/infected wounds are associated with an increased risk of surgical site infection
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005
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Table 2 Univariate analysis of risk factors for major complications following IPAA. Variable
Agea Race/Ethnicity Non-Hispanic White Hispanic White Black/African American Asian Other/Unknown Sex Male Female Diagnosis CUC FAP Body Mass Index Missing Underweight Normal Overweight Obese History of asthma Biliary/Liver/Pancreatic Disease Cardiac Risk Factors Steroids and Immunosuppressant Use Steroid and immunosuppressant Steroid only Immunosuppressant only Neither Weight loss or failure to thrive Preoperative SIRS Preoperative hematocrita Preoperative white blood cell counta Preoperative platelet counta Preoperative albumina ASA class I–II III Operation Status Elective Urgent Hospital Admission 3 or more days prior to surgery Yes No Wound Classification Clean Clean–Contaminated Contaminated Dirty/Infected Operative Time Quartiles (min) b242 243–322 323–408 409+ Laparoscopic Approach
No Major Complication (N = 152)
Major Complication (N = 43)
14 (11–16)
14 (11–16)
115 (75.7) 13 (8.6) 16 (10.5) 1 (0.7) 7 (4.6)
33 (76.7) 3 (7.0) 6 (14.0) 0 (0.0) 1 (2.3)
67 (44.1) 85 (55.9)
20 (46.5) 23 (53.5)
73 (48.0) 79 (52.0)
26 (60.5) 17 (39.5)
10 8 (5.6) 87 (61.3) 26 (18.3) 21 (14.8) 12 (7.9) 7 (5.3) 1 (0.7)
2 2 (4.9) 27 (65.9) 6 (14.6) 6 (14.6) 1 (2.3) 3 (8.1) 0(0.0)
P value 0.75 0.91
0.86
0.17
0.97
3 (2.0) 5 (11.6) 19 (12.5) 6 (14.0) 8 (5.3) 2 (4.7) 122 (80.3) 30 (69.8) 4 (3.6) 1 (3.4) 1 (0.7) 3 (7.0) 37.1 (34.9–40.6) 37.0 (32.0–39.1) 6.9 (5.8–8.5) 9.4 (6.5–13.7) 300 (257–356) 345 (282–382) 4.1 (3.6–4.5) 4.0 (3.5–4.3) 115 (75.7) 37 (24.3)
28 (65.1) 15 (34.9)
151 (99.3) 1 (0.7)
42 (97.7) 1 (2.3)
0.30 0.46 1.0 0.06
1.0 0.03 0.14 0.01 0.11 0.59 0.18
0.39
0.05 8 (5.3) 144 (94.7)
6 (14.0) 37 (86.0)
2 (1.3) 131 (86.2) 15 (9.9) 4 (2.6)
1 (2.3) 30 (69.8) 9 (20.9) 3 (7.0)
37 (24.3) 41 (27.0) 40 (26.3) 34 (22.4) 104 (68.4)
11 (25.6) 9 (20.9) 8 (18.6) 15 (34.9) 28 (65.1)
0.05
0.36
0.71
a
Data expressed as median and interquartile range; otherwise expressed as number and percent.
[11], which fits with the 30% of major complications we found being deep surgical site infections or organ space infections. In addition, the use of combination immunosuppression preoperatively and preoperative leukocytosis bordered on significance on multivariable analysis but did not reach it. Taken together, these two factors paint the picture of an ill patient with severe, medically refractory ulcerative colitis. Steroids have a well-known association with poor wound healing and anastomotic leak in abdominal surgery [12], and preoperative immunosuppression has repeatedly been shown to be an independent risk factor for the development of pelvic sepsis after IPAA in adult patients [12,13] and has been suggested as a risk factor in pediatrics [14]. Owing to the association of pelvic sepsis with subsequent pouch dysfunction and pouch failure [15], there has been a trend away from pouch formation in adult patients on multimodal immunosuppression [16]. These data suggest a similar approach should be taken in pediatric patients on combination immunosuppression with consideration of subtotal colectomy with end ileostomy initially and pouch formation at a later operation either in the traditional three stage method or as part of a modified two stage approach [17]. Though a laparoscopic approach was not associated with a decrease in major complications, it was associated with a decrease in minor complications. Lower risks of sSSI and UTI have not been previously demonstrated in pediatric patients undergoing laparoscopic IPAA in small, single-institutional studies. A reduction in these minor complications has been demonstrated in adult patients undergoing colorectal resections [18,19]. Obesity and immunosuppression were also found to be associated with an increased risk of minor complications in this data set, again reflecting observations in adult patients undergoing IPAA [20–22]. In addition to analyzing complications with respect to operative approach, the impact of laparoscopy on LOS was studied. Previous reports have varied with respect to LOS with some showing an association between laparoscopy and decreased length of stay and others showing no difference [3,5,23,24]. This is the first study to show on multivariable analysis that an open approach was independently associated with prolonged LOS after IPAA in a pediatric population of FAP patients. Further, an open approach also trended towards significance in the model for prolonged LOS in the overall group and the CUC group. We surmise that the physiologic status of some children with CUC contributes to prolonged lengths of stay after TPC-IPAA in both the open and laparoscopic groups. Overall, the laparoscopic approach to IPAA has been shown to have earlier time to diet and less analgesic requirements postoperatively [5], both of which decrease time to discharge, as reflected by the histogram in Fig. 1. Other risk factors for prolonged LOS included having a major complication prior to discharge and being a racial minority. Complications in the hospital have consistently been shown to be associated with increased lengths of stay in colorectal surgery [25,26]. Black/African American race/ethnicity being associated with prolonged LOS in both the overall cohort and the CUC cohort is a new finding. This could perhaps indicate suboptimal medical management of ulcerative colitis preoperatively in minorities, as race/ethnicity did not play a role in prolonged LOS in FAP only patients. Black/African American race/ ethnicity has been shown to be associated with increased complications
Table 3 Multivariable model of major complication in IPAA. Variable
Level
Odds Ratio (95% CI)
P value
Admission for 3 or more days before surgery WBC count N13.5 (reference no)
Yes Yes Missing Laparoscopic Contaminated or Dirty/Infected Steroid and immunosuppressant use Steroid only Immunosuppressant only
1.6 (0.4–6.6) 4.1 (0.9–18.7) 1.2 (0.5–2.3) 0.9 (0.4–1.8) 2.6 (1.1–6.4) 3.6 (0.6–20.6) 0.8 (0.3–2.8) 0.6 (0.1–3.7)
0.53 0.07 0.70 0.68 0.04 0.16 0.79 0.62
Surgical approach Wound Classification (reference: clean or clean–contaminated) Steroid and immunosuppressant use (reference: neither)
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005
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Table 4 Multivariable models for prolonged length of stay. Variable
Level
CUC and FAP OR (95% CI), P value
CUC OR (95% CI), P value
FAP OR (95% CI), P value
Race (reference: Non-Hispanic White)
Black or African American Other CUC Yes Neither Open Yes Missing III Contaminated or Dirty/Infected Yes Yes
4.4 (1.5–13.4), b0.01 3.2 (1.1–9.6), 0.04 1.2 (0.5–2.8), 0.65 ------2.1 (1.0–4.7), 0.06 1.3 (0.2–6.7), 0.77 0.4 (0.2–1.0), 0.04 1.8 (0.8–4.2), 0.17 2.3 (0.9–5.9), 0.09 9.1 (3.7–22.6), b0.01 5.0 (0.6–41.7), 0.13
16.5 (2.4–114.1), b0.01 1.5 (0.3–8.5), 0.60 ------2.8 (1.0–7.8), 0.05 2.4 (0.8–6.7), 0.10 ----
----
------6.5 (2.2–19.5), b0.01 2.0 (0.1–33.9), 0.60
------21.1 (5.3–85.0), b0.01 ----
Diagnosis (reference: FAP) History of asthma (reference: no) Steroid or Immunosuppressant Use Surgical approach (reference: lap) White blood cell N13.5 (reference: no) ASA (reference: ASA I–II) Wound classification (reference: clean or clean–contaminated) Major Complication Prior to Discharge (reference: no) Minor Complication Prior to Discharge (reference: no)
in adult patients undergoing surgery for Crohn's disease owing to inferior preoperative disease management [27]. There are several limitations inherent to this study owing to its use of an existing large, multicenter database. First, information on the specific immunosuppressive regimens used in the patients with chronic ulcerative colitis is not available. Second, we could not examine the impact of laparoscopy on patients undergoing completion proctectomy with IPAA. Third, while the CPTs for pouch formation include ileostomy formation in their definition, it is possible some patients were not diverted at the operation. We do not feel this would impact the results significantly as omission of ileostomy has not been shown to impact complications in pediatric patients to date [17]. We also cannot therefore comment on any patient differences between those who underwent one and two-stage procedures. Lastly, since ACS-NSQIP only captures thirty-day complications, there are also no data available on long-term pouch function in these patients or the development of long-term small bowel obstruction. Despite these limitations, we were able to evaluate the use of laparoscopy in the largest cohort of pediatric patients undergoing IPAA to date. 4. Conclusion The laparoscopic approach to total proctocolectomy with ileal pouch anal anastomosis in pediatric patients independently resulted in lower odds of a prolonged LOS in FAP patients and was associated with decreased minor complications and an equivalent rate of major complications in all children undergoing TPC-IPAA. Taken together, these findings support
---7.3 (1.5–35.0), 0.01 ---4.0 (1.1–14.0), 0.03 ----
the continued preferential use of the laparoscopic approach to total proctocolectomy with IPAA in the pediatric population. Acknowledgment In kind support was provided by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. McKenna's salary is funded by the Mayo School of Graduate Medical Education Clinician Investigator program. No specific grant number is associated with the work. References [1] Kennedy RD, Zarroug AE, Moir CR, et al. Ileal pouch anal anastomosis in pediatric familial adenomatous polyposis: a 24-year review of operative technique and patient outcomes. J Pediatr Surg 2014;49(9):1409–12. [2] Polites SF, Potter DD, Moir CR, et al. Long-term outcomes of ileal pouch-anal anastomosis for pediatric chronic ulcerative colitis. J Pediatr Surg 2015;50(10):1625–9. [3] Sheth J, Jaffray B. A comparison of laparoscopic and open restorative proctocolectomy in children. J Pediatr Surg 2014;49(2):262–4 [discussion 4]. [4] Diamond IR, Gerstle JT, Kim PC, et al. Outcomes after laparoscopic surgery in children with inflammatory bowel disease. Surg Endosc 2010;24(11):2796–802. [5] Flores P, Bailez MM, Cuenca E, et al. Comparative analysis between laparoscopic (UCL) and open (UCO) technique for the treatment of ulcerative colitis in pediatric patients. Pediatr Surg Int 2010;26(9):907–11. [6] Fleming FJ, Francone TD, Kim MJ, et al. A laparoscopic approach does reduce shortterm complications in patients undergoing ileal pouch-anal anastomosis. Dis Colon Rectum 2011;54(2):176–82. [7] Klarenbeek BR, Veenhof AA, Bergamaschi R, et al. Laparoscopic sigmoid resection for diverticulitis decreases major morbidity rates: a randomized control trial: shortterm results of the Sigma trial. Ann Surg 2009;249(1):39–44.
Fig. 1. Length of stay in laparoscopic versus open IPAA; median [IQR]: 7 [5–9] days in laparoscopic group vs 8 [6–10] days in open group, p b 0.01.
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005
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[8] El Nakeeb A, Fikry A, El Metwally T, et al. Early oral feeding in patients undergoing elective colonic anastomosis. Int J Surg 2009;7(3):206–9. [9] Biondi A, Grosso G, Mistretta A, et al. Laparoscopic-assisted versus open surgery for colorectal cancer: short- and long-term outcomes comparison. J Laparoendosc Adv Surg Tech A 2013;23(1):1–7. [10] Tan YW, Jaffray B. A comparison of open and laparoscopic restorative proctocolectomy in children. Pediatr Surg Int 2009;25(10):877–9. [11] Ortega G, Rhee DS, Papandria DJ, et al. An evaluation of surgical site infections by wound classification system using the ACS-NSQIP. J Surg Res 2012;174(1):33–8. [12] Kiran RP, da Luz Moreira A, Remzi FH, et al. Factors associated with septic complications after restorative proctocolectomy. Ann Surg 2010;251(3):436–40. [13] Heuschen UA, Hinz U, Allemeyer EH, et al. Risk factors for ileoanal J pouch-related septic complications in ulcerative colitis and familial adenomatous polyposis. Ann Surg 2002;235(2):207–16. [14] Kennedy R, Potter DD, Moir C, et al. Pediatric chronic ulcerative colitis: does infliximab increase post-ileal pouch anal anastomosis complications? J Pediatr Surg 2012;47(1):199–203. [15] Kiely JM, Fazio VW, Remzi FH, et al. Pelvic sepsis after IPAA adversely affects function of the pouch and quality of life. Dis Colon Rectum 2012;55(4):387–92. [16] Gu J, Remzi FH, Shen B, et al. Operative strategy modifies risk of pouch-related outcomes in patients with ulcerative colitis on preoperative anti-tumor necrosis factoralpha therapy. Dis Colon Rectum 2013;56(11):1243–52. [17] Ryan DP, Doody DP. Restorative proctocolectomy with and without protective ileostomy in a pediatric population. J Pediatr Surg 2011;46(1):200–3. [18] Aimaq R, Akopian G, Kaufman HS. Surgical site infection rates in laparoscopic versus open colorectal surgery. Am Surg 2011;77(10):1290–4.
[19] Kang CY, Chaudhry OO, Halabi WJ, et al. Outcomes of laparoscopic colorectal surgery: data from the Nationwide Inpatient Sample 2009. Am J Surg 2012;204(6):952–7. [20] McKenna NP MK, Khasawneh MA, Dozois EJ, Larson DW, Pemberton JH, Lightner AL. Obese patients undergoing Ileal pouch-anal anastomosis: short- and long-term surgical outcomes. Inflamm Bowel Dis December 2017 In press. [21] Kiran RP, Remzi FH, Fazio VW, et al. Complications and functional results after ileoanal pouch formation in obese patients. J Gastrointest Surg 2008;12(4): 668–74. [22] Uchino M, Ikeuchi H, Matsuoka H, et al. Risk factors associated with surgical site infection after ileal pouch-anal anastomosis in ulcerative colitis. Dis Colon Rectum 2010;53(2):143–9. [23] Linden BC, Bairdain S, Shamberger RC, et al. Technique of laparoscopic-assisted total proctocolectomy and ileal pouch anal anastomosis in children and adolescents: a single center's 8-year experience. J Pediatr Surg 2012;47(12):2345–8. [24] Polites SF, Zarroug AE, Moir CR, et al. Single-incision laparoscopic ileal pouch-anal anastomosis in children—how does it compare to a laparoscopic-assisted approach? J Laparoendosc Adv Surg Tech A 2015;25(2):167–71. [25] Ricciardi R, Roberts PL, Read TE, et al. Which adverse events are associated with mortality and prolonged length of stay following colorectal surgery? J Gastrointest Surg 2013;17(8):1485–93. [26] Krell RW, Girotti ME, Dimick JB. Extended length of stay after surgery: complications, inefficient practice, or sick patients? JAMA Surg 2014;149(8):815–20. [27] Arsoniadis EG, Ho YY, Melton GB, et al. African Americans and short-term outcomes after surgery for Crohn's disease: an ACS-NSQIP analysis. J Crohns Colitis 2017;11 (4):468–73.
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005
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Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?☆,☆☆ Nicholas P. McKenna a,b,⁎, Donald D. Potter c, Katherine A. Bews b, Amy E. Glasgow b, Kellie L. Mathis d, Elizabeth B. Habermann a,b a
Department of Surgery, Mayo Clinic, Rochester, MN The Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN Division of Pediatric Surgery, Mayo Clinic, Rochester, MN d Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, MN b c
a r t i c l e
i n f o
Article history: Received 15 September 2018 Accepted 1 October 2018 Available online xxxx Key words: Laparoscopic surgery IPAA NSQIP CUC FAP
a b s t r a c t Purpose: The purpose of this study was to determine if a laparoscopic approach reduces complications and length of stay (LOS) after total proctocolectomy with ileal pouch-anal anastomosis (TPC-IPAA) in pediatric patients using a multicenter prospective database. Methods: The American College of Surgeons National Surgical Quality Improvement Project Pediatric database from 2012 to 2015 was used to identify patients with a diagnosis of chronic ulcerative colitis (CUC) or familial adenomatous polyposis (FAP) undergoing TPC-IPAA. Major complications, minor complications, and prolonged LOS were compared based on laparoscopic versus open approach. Results: 195 (108 female) patients underwent TPC-IPAA at a median age of 14 years (IQR: 11–16) for CUC (N = 99) or FAP (N = 96). Two-thirds of cases were laparoscopic. A laparoscopic approach was not associated with major complications, but lower odds of minor complications were observed. A reduced LOS was seen in laparoscopic versus open surgery (median LOS 6 vs 8 days, p b 0.01). Open IPAA was independently associated with prolonged LOS (N9 days) in the FAP cohort (OR 4.0, 95% CI 1.1–14.0). Conclusion: A laparoscopic approach was not associated with increased major complications but was associated with lower odds of minor complications and shorter LOS. The laparoscopic approach should continue to be preferred for pouch procedures in pediatric patients. Type of study: Treatment; retrospective study. Level of evidence: Level III. © 2018 Elsevier Inc. All rights reserved.
Ileal pouch-anal anastomosis (IPAA) is the surgical treatment of choice for patients with chronic ulcerative colitis (CUC) and familial adenomatous polyposis (FAP) owing to favorable long-term functional outcomes and a high-degree of patient satisfaction [1,2]. However, the short term morbidity associated with IPAA in pediatrics is substantial, ☆ Author Contribution. Study conception and design: Nicholas McKenna, Donald Potter, Kellie Mathis, Elizabeth Habermann. Acquisition of data: Nicholas McKenna, Katherine Bews, Amy Glasgow. Analysis and interpretation of data: Nicholas McKenna, Donald Potter, Katherine Bews, Amy Glasgow, Kellie Mathis, Elizabeth Habermann. Drafting of manuscript: Nicholas McKenna, Donald Potter, Elizabeth Habermann. Critical Revision of manuscript: Nicholas McKenna, Donald Potter, Katherine Bews, Amy Glasgow, Kellie Mathis, Elizabeth Habermann. ☆☆ How this paper will improve care: An analysis of the Pediatric NSQIP database demonstrates that a laparoscopic approach does not increase complications after IPAA and is associated with a decreased length of stay compared to open surgery. A laparoscopic approach should continue to be preferred. ⁎ Corresponding author at: Mayo Clinic, 200 1st St SW, Rochester, MN 55905. Tel.: +1 507 266 6176. E-mail address: [email protected] (N.P. McKenna).
with complication rates ranging from 30% [3] to 60% [4] and postoperative stays commonly exceeding two weeks in length [3,5]. In an effort to curtail length of stay (LOS) and potentially reduce complications, the laparoscopic approach to IPAA has been adopted in pediatric surgery. Studies in adult patients have demonstrated that the laparoscopic approach to IPAA and other colorectal procedures reduces the risk of short-term major and minor complications [6,7]. Laparoscopic surgery also allows earlier feeding [8] and patients have less postoperative analgesic requirements [9]. However, owing to the small sample sizes of single-institution studies, none of the studies examining IPAA in a pediatric population have shown a reduction in short-term complications with the use of a laparoscopic approach, and estimates of its effect on LOS have varied widely [3,5,10]. We believe that a laparoscopic approach does not result in increased major complications and simultaneously decreases the risk of prolonged LOS, but that prior studied did not have large enough samples to demonstrate this. Therefore, the aims of this study were to determine whether a laparoscopic approach reduces the incidence of major
https://doi.org/10.1016/j.jpedsurg.2018.10.005 0022-3468/© 2018 Elsevier Inc. All rights reserved.
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005
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and minor complications after total proctocolectomy with IPAA and to investigate if a laparoscopic approach reduced the risk of a prolonged LOS in pediatric patients using a large, prospectively maintained multicenter database. 1. Methods 1.1. Data source The American College of Surgeons National Surgical Quality Improvement Project (ACS NSQIP) Pediatric data from 2012 to 2015 were utilized. Trained surgical clinical reviewers at each site collect and submit the data from the preoperative period until thirty-days postoperatively. Audits are routinely performed to ensure high quality, accurate data. ACS-NSQIP data are deidentified and exempt from review by the institutional review board at our institution. 1.2. Cohort and outcomes All patients less than 18 years old undergoing a total proctocolectomy with ileal pouch-anal anastomosis (TPC-IPAA: CPT codes: 44157, 44158, and 44211) for CUC (defined by ICD-9556.x or ICD-10K51.xx) or FAP (defined by ICD-9211.3 or ICD-10 D12.1-D12.8) were included. CPT 44157 and 44158 are open approach procedures and CPT 44211 is a laparoscopic approach procedure. Patients undergoing proctectomy only with IPAA were excluded from analysis secondary to the lack of individual laparoscopic and open CPT codes for this procedure. The primary outcome of interest was the occurrence of any major complication. The categorical outcome of any major complication was chosen instead of the total number of major complications owing to the relationship between many of the major complications, for example sepsis and progressive renal insufficiency. Major complications included: deep incisional surgical site infection, wound disruption, organ space infection, pneumonia, unplanned reintubation, progressive renal insufficiency, acute renal failure, blood transfusion, deep venous thrombosis, pulmonary embolism, postoperative sepsis/septic shock, return to the operating room, and death. Secondary outcomes included the occurrence of a minor complication (defined as a superficial surgical site infection [sSSI] or a urinary tract infection [UTI]) and the occurrence of a prolonged LOS. Since 99% of operations were elective, LOS was defined as total hospitalization length, and prolonged LOS was defined as an initial hospitalization longer than the 75th percentile. 1.3. Covariates Patient level variables included sex, race/ethnicity, age, body mass index (underweight: less than the 5th percentile, normal: 5th to 85th percentile, overweight: 85th to 95th percentile, and obese: greater than the 95th percentile) and diagnosis (CUC or FAP). Preoperative comorbidities included history of asthma, biliary/pancreatic/liver disease, and cardiac conditions and preoperative medications included immunosuppressant use or the presence of an immunodeficiency within 30 days of the operation (only available 2012 to July 2015) and steroid use within 30 days of the operation. For the purposes of analyzing major complications, the steroids variable and immunosuppressant variable were combined and grouped into 4 categories: combined therapy, steroids only, immunosuppressant therapy only, and no medications. For the prolonged LOS model in the CUC cohort, medications were grouped as steroids and/or immunosuppressants versus none. Preoperative lab values included hematocrit, white blood cell count, platelet count, and serum albumin. Perioperative and intraoperative variables included ASA class, wound classification, and operative duration. Missing data were excluded from univariate analysis for both categorical and continuous variables, and for multivariable analysis, a missing group was created.
1.4. Statistical analysis Preoperative patient characteristics were compared between those undergoing laparoscopic or open IPAA using χ 2 or Fisher exact test for categorical variables and Wilcoxon rank-sum test and Student t-test for continuous variables. The occurrence of a major complication, of a minor complication, and of prolonged LOS (in the entire cohort as well as in CUC only and FAP only cohorts) was analyzed as a binary outcome on univariate analysis using the previously mentioned tests as appropriate. Multivariable logistic regression was then conducted for the occurrence of major complications, prolonged LOS in the entire cohort, and prolonged LOS in the CUC and FAP cohorts individually. Additionally, a multivariable analysis was performed only for patients in the overall cohort and CUC cohorts who had surgery on hospital day 0 or 1 to determine if total hospital stay was skewed by patients admitted for extended periods preoperatively. All patients in the FAP cohort had surgery on hospital day 0 or 1. Multivariable analysis was not performed on the occurrence of a minor complication secondary to a limited number of events. Covariates significant on univariate analysis or deemed clinically relevant (wound classification, preoperative steroid/immunosuppressant use) were chosen for inclusion in the major complications model and the prolonged LOS models. Statistical analysis was performed using SAS 9.4 software (SAS Institute, Cary, NC) with significance set at p b 0.05. 2. Results 2.1. Clinical characteristics and operative characteristics 195 (55% female) patients underwent TPC-IPAA at a median age of 14 years (IQR: 11–16) for CUC (N = 99) or FAP (N = 96). Two-thirds of cases (N = 132) were performed laparoscopically. The two groups did not differ on preoperative clinical characteristics, though an increased percentage of obese children underwent open IPAA. Operative time did not differ between the laparoscopic and open group (Table 1). 2.2. Major and minor complications There were a total of 63 major complications in 43 patients. A laparoscopic approach did not reach significance on univariate analysis of having a major complication, but preoperative leukocytosis and preoperative systemic inflammatory response (SIRS) did (both p b 0.05). A multivariable model for sustaining a major complication was built with leukocytosis, wound classification, and steroid/immunosuppressant use included. A wound classification of contaminated or dirty/infected versus clean or clean–contaminated was a significant predictor of having a major complication (odds ratio: 2.7, 95% CI 1.1–6.6). Preoperative combination immunosuppression with a steroid and an immunosuppressant and preoperative leukocytosis did not reach significance for having a major complication. Full results from the univariate and multivariable are available in Tables 2 and 3. There were 12 minor complications in 12 patients. A laparoscopic approach was associated with a lower rate of minor complications (p = 0.02) on univariate analysis as compared to open surgery. Obesity and preoperative immunosuppressant use were also associated with the occurrence of a minor complication (both p b 0.05). 2.3. Length of stay Median LOS was 7 days (interquartile range [IQR] 5–9) in those without a major complication prior to discharge, and it increased to 13.5 days (IQR 8–19) in patients with a major complication prior to discharge. A laparoscopic approach was associated with a decreased LOS compared to open surgery (median [IQR]: 7 [5–9] vs 9 [6–12] days, p b 0.01) in all patients, as well as a decreased LOS in those without a
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005
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Table 1 Preoperative clinical characteristics and operative characteristics of entire cohort. Clinical Characteristics Agea Race/Ethnicity Non-Hispanic White Hispanic White Black/African American Asian Other/Unknown Sex Male Female Diagnosis CUC FAP Body Mass Index Missing Underweight Normal Overweight Obese History of asthma Biliary/Liver/Pancreatic Disease Cardiac Risk Factors Steroids Immunosuppressants/Immunodeficiency Weight loss or failure to thrive Preoperative SIRS Preoperative hematocrita Preoperative white blood cell counta Preoperative platelet counta Preoperative albumina Operative Characteristics ASA class I–II III Case status Elective Urgent Wound Class Clean Clean/Contaminated Contaminated Dirty/Infected Operative Time, min b242 243–322 323–408 409–761 Days from operation to dischargea a
Total Cohort (n = 195) 14 (11–16)
Laparoscopic Group (n = 132) 14 (11.5–16)
Open Group (n = 63) 14 (10–16)
148 (75.9) 16 (8.2) 22 (11.3) 1 (0.5) 8 (4.1)
101 (76.5) 12 (9.1) 15 (11.4) 1 (0.8) 3 (2.3)
47 (74.6) 4 (6.3) 7 (11.1) 0 (0.0) 5 (7.9)
87 (44.6) 108 (55.4)
60 (45.5) 72 (54.5)
27 (42.9) 36 (57.1)
99 (50.8) 96 (49.2)
65 (49.2) 67 (50.8)
34 (54.0) 29 (46.0)
p-value 0.65 0.39
0.76
0.54
0.10 12 10 (5.5) 114 (62.3) 32 (17.5) 27 (14.8) 13 (6.7) 10 (5.9) 1 (0.5) 33 (16.9) 18 (10.7) 5 (3.6) 4 (2.1) 37.0 (34.0–40.3) 7.4 (5.8–9.7) 309 (258–363) 4.0 (3.5–4.4)
7 8 (6.4) 77 (61.6) 26 (20.8) 14 (11.2) 8 (6.1) 6 (5.1) 1 (0.8) 23 (17.4) 13 (11.1) 4 (4.3) 3 (2.3) 37.1 (34.9–40.0) 7.4 (6.2–10.2) 320 (260–363) 4.0 (3.7–4.5)
5 2 (3.4) 37 (63.8) 6 (10.3) 13 (22.4) 5 (7.9) 4 (7.7) 0 (0.0) 10 (15.9) 5 (9.6) 1 (2.2) 1 (1.6) 37.0 (33.8–40.3) 7.2 (5.2–9.5) 287 (252–363) 4.0 (2.8–4.3)
0.76 0.50 1.0 0.84 1.0 1.0 1.0 0.87 0.48 0.20 0.44 0.61
143 (73.3) 52 (26.7)
95 (72.0) 37 (28.0)
48 (76.2) 15 (23.8)
193 (99.0) 2 (1.0)
131 (99.2) 1 (0.8)
62 (98.4) 1 (1.6)
3 (1.5) 161 (82.6) 24 (12.3) 7 (3.6)
3 (2.3) 109 (82.6) 15 (11.4) 5 (3.8)
0 (0.0) 52 (82.5) 9 (14.3) 2 (3.2)
48 (24.6) 50 (25.6) 48 (24.6) 49 (25.1) 7 (5–9)
28 (21.2) 36 (27.3) 34 (25.8) 34 (25.8) 6 (5–9)
20 (31.7) 14 (22.2) 14 (22.2) 15 (23.8) 8 (6–10)
0.54
0.77
0.48
b0.01
Data expressed as median and interquartile range; otherwise expressed as number and percent.
major complication prior to discharge (median [IQR]: 6 [5–8] vs 8 [6–10] days, p b 0.01). Univariate analysis of risk factors for prolonged LOS in the entire group revealed race/ethnicity, laparoscopic surgery, wound classification, a major complication prior to discharge, and a minor complication prior to discharge to be significant (all p b 0.05). In the CUC cohort, factors associated with prolonged LOS included race/ethnicity and having a major complication prior to discharge (both p b 0.05), and in the FAP cohort a history of asthma and having a major complication prior to discharge were significantly associated with prolonged LOS (both p b 0.05). On multivariable analysis, open surgery was associated with prolonged LOS in the FAP cohort, but did not reach significance in the overall cohort or CUC cohort. A major complication prior to discharge was an independent risk factor for prolonged LOS in all models. Full multivariable results are presented in Table 4. Multivariable analysis of just the patients operated on within 1 day of admission in the overall cohort along with CUC cohort revealed similar results with respect to the impact of open surgery and odds of prolonged length of stay (overall, odds ratio [95% confidence interval]: 1.85 [0.8–4.6]; CUC, 1.63 [0.4–6.2]).
3. Discussion While the laparoscopic approach to IPAA is preferred in adults owing to decreased postoperative pain, earlier return of bowel function, and decreased LOS, similar findings have not been demonstrated in pediatric patients. Using a large, multicenter database, we found no increase in major complications, a decreased rate of minor complications, and a reduced LOS with the use of a laparoscopic approach to total proctocolectomy with IPAA. These results support the continued performance of a laparoscopic total proctocolectomy with IPAA to all pediatric patients when clinically indicated. The 22% rate of experiencing one or more major complications in this study is comparable to smaller, single-center studies in pediatric patients [3,5]. Owing to small sample sizes in other pediatric studies on IPAA, a multivariable model of risk factors for major complications has not been built previously. We were able to develop the first multivariable model for major complications after pediatric IPAA, and the only independent risk factor identified was a wound classification of contaminated or dirty/infected. Contaminated and dirty/infected wounds are associated with an increased risk of surgical site infection
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005
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Table 2 Univariate analysis of risk factors for major complications following IPAA. Variable
Agea Race/Ethnicity Non-Hispanic White Hispanic White Black/African American Asian Other/Unknown Sex Male Female Diagnosis CUC FAP Body Mass Index Missing Underweight Normal Overweight Obese History of asthma Biliary/Liver/Pancreatic Disease Cardiac Risk Factors Steroids and Immunosuppressant Use Steroid and immunosuppressant Steroid only Immunosuppressant only Neither Weight loss or failure to thrive Preoperative SIRS Preoperative hematocrita Preoperative white blood cell counta Preoperative platelet counta Preoperative albumina ASA class I–II III Operation Status Elective Urgent Hospital Admission 3 or more days prior to surgery Yes No Wound Classification Clean Clean–Contaminated Contaminated Dirty/Infected Operative Time Quartiles (min) b242 243–322 323–408 409+ Laparoscopic Approach
No Major Complication (N = 152)
Major Complication (N = 43)
14 (11–16)
14 (11–16)
115 (75.7) 13 (8.6) 16 (10.5) 1 (0.7) 7 (4.6)
33 (76.7) 3 (7.0) 6 (14.0) 0 (0.0) 1 (2.3)
67 (44.1) 85 (55.9)
20 (46.5) 23 (53.5)
73 (48.0) 79 (52.0)
26 (60.5) 17 (39.5)
10 8 (5.6) 87 (61.3) 26 (18.3) 21 (14.8) 12 (7.9) 7 (5.3) 1 (0.7)
2 2 (4.9) 27 (65.9) 6 (14.6) 6 (14.6) 1 (2.3) 3 (8.1) 0(0.0)
P value 0.75 0.91
0.86
0.17
0.97
3 (2.0) 5 (11.6) 19 (12.5) 6 (14.0) 8 (5.3) 2 (4.7) 122 (80.3) 30 (69.8) 4 (3.6) 1 (3.4) 1 (0.7) 3 (7.0) 37.1 (34.9–40.6) 37.0 (32.0–39.1) 6.9 (5.8–8.5) 9.4 (6.5–13.7) 300 (257–356) 345 (282–382) 4.1 (3.6–4.5) 4.0 (3.5–4.3) 115 (75.7) 37 (24.3)
28 (65.1) 15 (34.9)
151 (99.3) 1 (0.7)
42 (97.7) 1 (2.3)
0.30 0.46 1.0 0.06
1.0 0.03 0.14 0.01 0.11 0.59 0.18
0.39
0.05 8 (5.3) 144 (94.7)
6 (14.0) 37 (86.0)
2 (1.3) 131 (86.2) 15 (9.9) 4 (2.6)
1 (2.3) 30 (69.8) 9 (20.9) 3 (7.0)
37 (24.3) 41 (27.0) 40 (26.3) 34 (22.4) 104 (68.4)
11 (25.6) 9 (20.9) 8 (18.6) 15 (34.9) 28 (65.1)
0.05
0.36
0.71
a
Data expressed as median and interquartile range; otherwise expressed as number and percent.
[11], which fits with the 30% of major complications we found being deep surgical site infections or organ space infections. In addition, the use of combination immunosuppression preoperatively and preoperative leukocytosis bordered on significance on multivariable analysis but did not reach it. Taken together, these two factors paint the picture of an ill patient with severe, medically refractory ulcerative colitis. Steroids have a well-known association with poor wound healing and anastomotic leak in abdominal surgery [12], and preoperative immunosuppression has repeatedly been shown to be an independent risk factor for the development of pelvic sepsis after IPAA in adult patients [12,13] and has been suggested as a risk factor in pediatrics [14]. Owing to the association of pelvic sepsis with subsequent pouch dysfunction and pouch failure [15], there has been a trend away from pouch formation in adult patients on multimodal immunosuppression [16]. These data suggest a similar approach should be taken in pediatric patients on combination immunosuppression with consideration of subtotal colectomy with end ileostomy initially and pouch formation at a later operation either in the traditional three stage method or as part of a modified two stage approach [17]. Though a laparoscopic approach was not associated with a decrease in major complications, it was associated with a decrease in minor complications. Lower risks of sSSI and UTI have not been previously demonstrated in pediatric patients undergoing laparoscopic IPAA in small, single-institutional studies. A reduction in these minor complications has been demonstrated in adult patients undergoing colorectal resections [18,19]. Obesity and immunosuppression were also found to be associated with an increased risk of minor complications in this data set, again reflecting observations in adult patients undergoing IPAA [20–22]. In addition to analyzing complications with respect to operative approach, the impact of laparoscopy on LOS was studied. Previous reports have varied with respect to LOS with some showing an association between laparoscopy and decreased length of stay and others showing no difference [3,5,23,24]. This is the first study to show on multivariable analysis that an open approach was independently associated with prolonged LOS after IPAA in a pediatric population of FAP patients. Further, an open approach also trended towards significance in the model for prolonged LOS in the overall group and the CUC group. We surmise that the physiologic status of some children with CUC contributes to prolonged lengths of stay after TPC-IPAA in both the open and laparoscopic groups. Overall, the laparoscopic approach to IPAA has been shown to have earlier time to diet and less analgesic requirements postoperatively [5], both of which decrease time to discharge, as reflected by the histogram in Fig. 1. Other risk factors for prolonged LOS included having a major complication prior to discharge and being a racial minority. Complications in the hospital have consistently been shown to be associated with increased lengths of stay in colorectal surgery [25,26]. Black/African American race/ethnicity being associated with prolonged LOS in both the overall cohort and the CUC cohort is a new finding. This could perhaps indicate suboptimal medical management of ulcerative colitis preoperatively in minorities, as race/ethnicity did not play a role in prolonged LOS in FAP only patients. Black/African American race/ ethnicity has been shown to be associated with increased complications
Table 3 Multivariable model of major complication in IPAA. Variable
Level
Odds Ratio (95% CI)
P value
Admission for 3 or more days before surgery WBC count N13.5 (reference no)
Yes Yes Missing Laparoscopic Contaminated or Dirty/Infected Steroid and immunosuppressant use Steroid only Immunosuppressant only
1.6 (0.4–6.6) 4.1 (0.9–18.7) 1.2 (0.5–2.3) 0.9 (0.4–1.8) 2.6 (1.1–6.4) 3.6 (0.6–20.6) 0.8 (0.3–2.8) 0.6 (0.1–3.7)
0.53 0.07 0.70 0.68 0.04 0.16 0.79 0.62
Surgical approach Wound Classification (reference: clean or clean–contaminated) Steroid and immunosuppressant use (reference: neither)
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005
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Table 4 Multivariable models for prolonged length of stay. Variable
Level
CUC and FAP OR (95% CI), P value
CUC OR (95% CI), P value
FAP OR (95% CI), P value
Race (reference: Non-Hispanic White)
Black or African American Other CUC Yes Neither Open Yes Missing III Contaminated or Dirty/Infected Yes Yes
4.4 (1.5–13.4), b0.01 3.2 (1.1–9.6), 0.04 1.2 (0.5–2.8), 0.65 ------2.1 (1.0–4.7), 0.06 1.3 (0.2–6.7), 0.77 0.4 (0.2–1.0), 0.04 1.8 (0.8–4.2), 0.17 2.3 (0.9–5.9), 0.09 9.1 (3.7–22.6), b0.01 5.0 (0.6–41.7), 0.13
16.5 (2.4–114.1), b0.01 1.5 (0.3–8.5), 0.60 ------2.8 (1.0–7.8), 0.05 2.4 (0.8–6.7), 0.10 ----
----
------6.5 (2.2–19.5), b0.01 2.0 (0.1–33.9), 0.60
------21.1 (5.3–85.0), b0.01 ----
Diagnosis (reference: FAP) History of asthma (reference: no) Steroid or Immunosuppressant Use Surgical approach (reference: lap) White blood cell N13.5 (reference: no) ASA (reference: ASA I–II) Wound classification (reference: clean or clean–contaminated) Major Complication Prior to Discharge (reference: no) Minor Complication Prior to Discharge (reference: no)
in adult patients undergoing surgery for Crohn's disease owing to inferior preoperative disease management [27]. There are several limitations inherent to this study owing to its use of an existing large, multicenter database. First, information on the specific immunosuppressive regimens used in the patients with chronic ulcerative colitis is not available. Second, we could not examine the impact of laparoscopy on patients undergoing completion proctectomy with IPAA. Third, while the CPTs for pouch formation include ileostomy formation in their definition, it is possible some patients were not diverted at the operation. We do not feel this would impact the results significantly as omission of ileostomy has not been shown to impact complications in pediatric patients to date [17]. We also cannot therefore comment on any patient differences between those who underwent one and two-stage procedures. Lastly, since ACS-NSQIP only captures thirty-day complications, there are also no data available on long-term pouch function in these patients or the development of long-term small bowel obstruction. Despite these limitations, we were able to evaluate the use of laparoscopy in the largest cohort of pediatric patients undergoing IPAA to date. 4. Conclusion The laparoscopic approach to total proctocolectomy with ileal pouch anal anastomosis in pediatric patients independently resulted in lower odds of a prolonged LOS in FAP patients and was associated with decreased minor complications and an equivalent rate of major complications in all children undergoing TPC-IPAA. Taken together, these findings support
---7.3 (1.5–35.0), 0.01 ---4.0 (1.1–14.0), 0.03 ----
the continued preferential use of the laparoscopic approach to total proctocolectomy with IPAA in the pediatric population. Acknowledgment In kind support was provided by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. McKenna's salary is funded by the Mayo School of Graduate Medical Education Clinician Investigator program. No specific grant number is associated with the work. References [1] Kennedy RD, Zarroug AE, Moir CR, et al. Ileal pouch anal anastomosis in pediatric familial adenomatous polyposis: a 24-year review of operative technique and patient outcomes. J Pediatr Surg 2014;49(9):1409–12. [2] Polites SF, Potter DD, Moir CR, et al. Long-term outcomes of ileal pouch-anal anastomosis for pediatric chronic ulcerative colitis. J Pediatr Surg 2015;50(10):1625–9. [3] Sheth J, Jaffray B. A comparison of laparoscopic and open restorative proctocolectomy in children. J Pediatr Surg 2014;49(2):262–4 [discussion 4]. [4] Diamond IR, Gerstle JT, Kim PC, et al. Outcomes after laparoscopic surgery in children with inflammatory bowel disease. Surg Endosc 2010;24(11):2796–802. [5] Flores P, Bailez MM, Cuenca E, et al. Comparative analysis between laparoscopic (UCL) and open (UCO) technique for the treatment of ulcerative colitis in pediatric patients. Pediatr Surg Int 2010;26(9):907–11. [6] Fleming FJ, Francone TD, Kim MJ, et al. A laparoscopic approach does reduce shortterm complications in patients undergoing ileal pouch-anal anastomosis. Dis Colon Rectum 2011;54(2):176–82. [7] Klarenbeek BR, Veenhof AA, Bergamaschi R, et al. Laparoscopic sigmoid resection for diverticulitis decreases major morbidity rates: a randomized control trial: shortterm results of the Sigma trial. Ann Surg 2009;249(1):39–44.
Fig. 1. Length of stay in laparoscopic versus open IPAA; median [IQR]: 7 [5–9] days in laparoscopic group vs 8 [6–10] days in open group, p b 0.01.
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005
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[19] Kang CY, Chaudhry OO, Halabi WJ, et al. Outcomes of laparoscopic colorectal surgery: data from the Nationwide Inpatient Sample 2009. Am J Surg 2012;204(6):952–7. [20] McKenna NP MK, Khasawneh MA, Dozois EJ, Larson DW, Pemberton JH, Lightner AL. Obese patients undergoing Ileal pouch-anal anastomosis: short- and long-term surgical outcomes. Inflamm Bowel Dis December 2017 In press. [21] Kiran RP, Remzi FH, Fazio VW, et al. Complications and functional results after ileoanal pouch formation in obese patients. J Gastrointest Surg 2008;12(4): 668–74. [22] Uchino M, Ikeuchi H, Matsuoka H, et al. Risk factors associated with surgical site infection after ileal pouch-anal anastomosis in ulcerative colitis. Dis Colon Rectum 2010;53(2):143–9. [23] Linden BC, Bairdain S, Shamberger RC, et al. Technique of laparoscopic-assisted total proctocolectomy and ileal pouch anal anastomosis in children and adolescents: a single center's 8-year experience. J Pediatr Surg 2012;47(12):2345–8. [24] Polites SF, Zarroug AE, Moir CR, et al. Single-incision laparoscopic ileal pouch-anal anastomosis in children—how does it compare to a laparoscopic-assisted approach? J Laparoendosc Adv Surg Tech A 2015;25(2):167–71. [25] Ricciardi R, Roberts PL, Read TE, et al. Which adverse events are associated with mortality and prolonged length of stay following colorectal surgery? J Gastrointest Surg 2013;17(8):1485–93. [26] Krell RW, Girotti ME, Dimick JB. Extended length of stay after surgery: complications, inefficient practice, or sick patients? JAMA Surg 2014;149(8):815–20. [27] Arsoniadis EG, Ho YY, Melton GB, et al. African Americans and short-term outcomes after surgery for Crohn's disease: an ACS-NSQIP analysis. J Crohns Colitis 2017;11 (4):468–73.
Please cite this article as: McKenna NP, et al, Ileal-pouch anal anastomosis in pediatric NSQIP: Does a laparoscopic approach reduce complications and length of stay?, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.005