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Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction
YJPSU-58850; No of Pages 5 Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction☆,☆☆ Allison F. Linden a,⁎, Manish T. Raiji a, Jonathan E. Kohler b, Erica M. Carlisle c, J. Carlos Pelayo d, Kate Feinstein e, Jessica J. Kandel a, Grace Z. Mak a a
University of Chicago Medicine Comer Children's Hospital, 5841 S. Maryland Ave, MC 4062, Chicago, IL, USA 60637 University of Wisconsin School of Medicine and Public Health, 600 Highland Ave, MC 7375, Madison, WI, USA 53792 University of Iowa Children's Hospital, 200 Hawkins Drive, Iowa City, IA, USA 52242 d Children's Hospital Los Angeles, Keck School of Medicine, 4650 Sunset Blvd, Mailstop 100, Los Angeles, CA, USA 90027 e University of Chicago Medicine Comer Children's Hospital, 5841 S. Maryland Ave, MC 2026, Chicago, IL, USA 60637 b c
a r t i c l e
i n f o
Article history: Received 24 September 2018 Accepted 1 October 2018 Available online xxxx Key word: Pediatric adhesive small bowel obstruction
a b s t r a c t Background/purpose: We examined outcomes before and after implementing an enteral water-soluble contrast protocol for management of pediatric adhesive small bowel obstruction (ASBO). Methods: Medical records were reviewed retrospectively for all children admitted with ASBO between November 2010 and June 2017. Those admitted between November 2010 and October 2013 received nasogastric decompression with decision for surgery determined by surgeon judgment (preprotocol). Patients admitted after October 2013 (postprotocol) received water-soluble contrast early after admission, were monitored with serial examinations and radiographs, and underwent surgery if contrast was not visualized in the cecum by 24 h. Group outcomes were compared. Results: Twenty-six patients experienced 29 admissions preprotocol, and 11 patients experienced 12 admissions postprotocol. Thirteen (45%) patients admitted preprotocol underwent surgery, versus 2 (17%) postprotocol patients (p = 0.04). Contrast study diagnostic sensitivity as a predictor for ASBO resolution was 100%, with 90% specificity. Median overall hospital LOS trended shorter in the postprotocol group, though was not statistically significant (6.2 days (preprotocol) vs 3.6 days (postprotocol) p = 0.12). Pre- vs. postprotocol net operating cost per admission yielded a savings of $8885.42. Conclusions: Administration of water-soluble contrast after hospitalization for pediatric ASBO may play a dual diagnostic and therapeutic role in management with decreases in surgical intervention, LOS, and cost. Type of study: Retrospective comparative study. Level of evidence: Level III. © 2018 Elsevier Inc. All rights reserved.
☆ Author Contribution Study conception and design: Linden, AF; Kohler, JE; Feinstein, K; Mak, GZ. Acquisition of data: Linden, AF; Raiji, MT; Kohler, JE; Carlisle, EM; Pelayo, JC; Feinstein, K; Kandel, JJ; Mak, GZ. Analysis and interpretation of data: Linden, AF; Raiji, MT; Kohler, JE; Kandel, JJ; Mak, GZ. Drafting of manuscript: Linden, AF; Raiji, MT; Kohler, JE; Carlisle, EM; Mak, GZ. Critical revision of manuscript: Linden, AF; Raiji, MT; Kohler, JE; Carlisle, EM; Pelayo, JC; Feinstein, K; Kandel, JJ; Mak, GZ ☆☆ How this paper will improve care: Enteral water-soluble contrast can have a diagnostic as well as therapeutic role in management of pediatric adhesive small bowel obstruction. This strategy can result in decreased surgical intervention, hospital length of stay, and cost. ⁎ Corresponding author. Tel.: +1 202 903 6031. E-mail addresses: [email protected] (A.F. Linden), [email protected] (M.T. Raiji), [email protected] (J.E. Kohler), [email protected] (E.M. Carlisle), [email protected] (J.C. Pelayo), [email protected] (K. Feinstein), [email protected] (J.J. Kandel), [email protected] (G.Z. Mak).
Small bowel obstruction owing to adhesive disease is a significant contributor to postoperative morbidity in children [1]. Further, operative treatment for adhesive disease is comparatively high-risk, with as many as one third of adult patients sustaining further bowel injury during adhesiolysis procedures [2]. Thus, the availability of an effective nonoperative intervention could result in decreased patient morbidity, increased patient safety, decreased hospital length of stay, and cost savings. Enteral water-soluble contrast has been used as a successful nonoperative diagnostic and therapeutic intervention for adhesive small bowel obstruction (ASBO) in the adult population for decades [3–6]. As a diagnostic tool, enteral contrast transit from the stomach to the colon has been reported to predict nonoperative resolution of ASBO with 96% sensitivity and 98% specificity [6]. Further, patients treated using this nonoperative strategy demonstrate reduction in need for surgery and shorter time to resolution of bowel obstruction [6].
https://doi.org/10.1016/j.jpedsurg.2018.10.002 0022-3468/© 2018 Elsevier Inc. All rights reserved.
Please cite this article as: Linden AF, et al, Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.002
2
A.F. Linden et al. / Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
The effect of this intervention strategy in children with ASBO is relatively unknown, especially because intestinal obstruction may have a different pathophysiologic course. Younger children and those within their first postoperative year experience higher risks of readmission and reoperation, as compared to an increased risk of readmission over time in adults [7,8]. Despite this difference, the nonoperative approach to pediatric ASBO has been reported to be effective without increased morbidity or mortality [9]. The use of water-soluble contrast in the nonoperative treatment of pediatric ASBO has been sparsely characterized, though [10–12]. Further, these prior reports implement contrast protocols only after failure of 48 h of decompressive management. We sought to test the diagnostic and therapeutic effect of watersoluble contrast in management of pediatric ASBO by comparing outcomes before and after initiating a patient treatment protocol early in hospitalization. 1. Methods A retrospective review of medical records was performed on all children admitted with ASBO to University of Chicago Comer Children's Hospital (Chicago, IL) between November 2010 and June 2017. Records were identified based on CPT codes indicating bowel obstruction. The diagnosis of ASBO was made based on clinical and radiologic findings. Hospital cost data for all admissions between November 2013 to October 2016 were obtained. Before November 2013, patients less than 18 years of age who presented without peritonitis, clinical suspicion of strangulation or suspicion for nonadhesive small bowel obstruction were treated with nonoperative decompression. This consisted of no enteral intake, gastric decompression, and intravenous hydration. Failure of nonoperative
treatment was determined on a clinical basis by individual surgeons, at which time surgery was generally recommended. After November 2013, a clinical protocol was initiated involving administration of enteral water-soluble contrast (diatrizoate meglumine, Cystografin, Bracco Diagnostics, New Jersey, USA) for all those admitted with ASBO (Fig. 1). All pediatric surgeons at the institution adhered to the protocol. Diatrizoate meglumine was chosen owing to its lower osmolar load compared to other enteral contrast solutions, thereby minimizing fluid shifts. Inclusion criteria consisted of a history of abdominal surgery, presentation with signs of bowel obstruction (either a first episode or recurrent episode), and radiographic evidence of small bowel obstruction on computed tomography (CT) or plain radiographs. Exclusion criteria for this protocol were clinical signs of peritonitis, clinical suspicion of strangulation, known active malignancy, and known/suspicion for nonadhesive small bowel obstruction. Diatrizoate meglumine was administered as early as possible in the patient's admission or after consultation by surgery. Dosage was agedependent, with children age 8 years or older receiving 200 mL, and those under age 8 years receiving 100 mL. Contrast was administered via nasogastric tube (or gastrostomy tube if one was previously in place). The nasogastric tube was placed to suction for one hour before contrast administration. The nasogastric or gastric tube was then clamped for one hour after contrast administration. An abdominal plain radiograph was obtained at 10 h and 24 h after contrast administration. Management was considered successful if contrast had passed to the cecum by the 24 h film along with clinical improvement. If achieved, the nasogastric tube was removed and feeding was started. If contrast failed to reach the cecum after 24 h, this was deemed complete obstruction, the nonoperative strategy was considered to have failed, and surgical intervention was recommended.
Fig. 1. Flow diagram of enteral water-soluble contrast protocol.
Please cite this article as: Linden AF, et al, Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.002
A.F. Linden et al. / Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
Patient demographics, clinical history and hospital course for ASBO were abstracted for all patients. Primary outcomes assessed were percentage of ASBO resolved after diatrizoate meglumine administration, hospital length of stay (LOS) and net operating costs. Demographic and outcomes data were described as medians for quantitative variables and numbers for categorical variables. Chi square and Fisher's exact tests were used to compare categorical variables, where appropriate. Student's T-test and Mann Whitney U were used to compare continuous variables. Patients readmitted during the same time period (preprotocol or postprotocol) were counted once under patient characteristics. Each admission was treated separately when analyzing patient admission characteristics and outcomes. Statistical significance was defined as p b 0.05. Ethical approval for the retrospective review was obtained from the University of Chicago Institutional Review Board. 2. Results In the preprotocol period (November 2010 through October 2013) 26 patients experienced 29 admissions for ASBO (16 boys, 10 girls; age range 1–19 years old). In the postprotocol period (November 2013 through June 2017) 11 patients experienced 12 admissions for ASBO (10 boys, 1 girl; age range 8 months–20 years old). (Table 1). There were no significant differences in comorbidities, age at admission or other admission clinical parameters between the pre- and postprotocol groups (Table 2). In the postprotocol group, 50% of patients demonstrated contrast in the cecum at 10 h postadministration, with this group representing 60% of those ultimately able to be managed nonoperatively. Further, 90% of those children with contrast in the cecum at 24 h showed radiological and clinical improvement. One patient without contrast in the cecum at 24 h was monitored on clinical grounds for another 19 h. A repeat radiograph demonstrated contrast in the colon, concurrent with clinical improvement, and the patient did not require surgery. The sensitivity and specificity of diatrizoate meglumine as a diagnostic tool for pediatric SBO resolution were 100% and 90%, respectively. Of the 29 admissions in the preprotocol group, 13 (45%) underwent surgery (Table 3). This was significantly different than the postprotocol group, in which 2 of the 12 admissions (17%) failed to demonstrate
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Table 2 Patient characteristics on admission for small bowel obstruction.
Age (years) at admission, median (IQR) Weight (kg) at admission, median (IQR) HR on admission, median (IQR) SBP on admission, median (IQR) DBP on admission, median (IQR) WBC on admission (median)
Preprotocol
Postprotocol
p-value
14.4 (7.4) 36 (39) 104 (31) 115 73 9.0 (6.1)
11.3 (17.9) 32 (37) 89.5 (48) 117 69 9.4 (5.4)
0.69 0.35 0.75 0.52 0.56 0.23
IQR = interquartile range.
contrast in the cecum and required surgery (p = 0.04). Median overall hospital LOS trended shorter in the postprotocol group, though was not statistically significant (6.2 days (preprotocol) vs 3.6 days (postprotocol); p = 0.12). No patients were readmitted within 30 days in the postprocotol cohort. Further, median hospital LOS for nonoperative patients was slightly shorter in the postprotocol group, but not statistically significant (3.5 days (preprotocol) vs 3.1 days (postprotocol); p = 0.56). When comparing median hospital LOS from therapeutic intervention (surgery in the preprotocol group and diatrizoate meglumine administration in the post protocol group) there is a statistically significant difference between the two cohorts (6.9 vs. 2.9 days; p = 0.003). In regards to healthcare resources, postprotocol patients underwent significantly fewer CTs than preprotocol patients (79% of preprotocol patients vs. 17% of postprotocol patients, p b 0.01) (Table 3). In addition, there was a meaningful difference in estimated net operating cost per admission between pre- and postprotocol patients ($16,974.07 (preprotocol) vs. $8088.65 (postprotocol) (Table 4)). Estimated median net operating cost difference between operative and nonoperative patients was also substantial (preprotocol, estimated median net operating cost difference: $18,772.16; postprotocol, median net operating cost difference: $20,261.50). 3. Discussion Pediatric ASBO imposes significant morbidity on postoperative patients and consumes substantial healthcare resources [13]. Our data indicate that a treatment protocol utilizing water-soluble contrast
Table 1 Patient characteristics.
Total number of admissions for small bowel obstruction Number of patients Males, n (%) (per number of patients) Admissions with at least 1 comorbidity, n (%) Primary diagnosis for initial abdominal surgery Appendicitis Battery ingestion Cloaca Congenital diaphragmatic hernia Congenital mesenteric band Congenital urogenital malformation Duodenal atresia, malrotation Failure to thrive Inflammatory bowel disease Intussusception Meconium cyst Necrotizing enterocolitis Meckel's diverticulum Retroperitoneal cancer Spontaneous intestinal perforation Ovarian torsion Trauma Volvulus Unknown Number previous abdominal surgeries (median) Admissions with history of at least 2 abdominal surgeries in the past, n (%)
Preprotocol
Postprotocol
p-value
29 26 16 (62) 13 (50)
12 11 10 (91) 9 (82)
0.12 0.14
3 1 1 1 1 2 1 1 3
2
1
2 1 1 1 1
3 2 1 4 1 2 1 11 (42)
1 2 7 (64)
0.30
Please cite this article as: Linden AF, et al, Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.002
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Table 3 Patient outcomes. Preprotocol Postprotocol p-value Length of Stay (LOS) Overall hospital LOS (days), median (IQR) Hospital LOS for nonoperative patients (days), median (IQR)
6.2 (5.9) 3.5 (2.2)
Need for Surgery Number of admissions requiring surgery, n (%) 13 (45) Number of hours between admission and 40 (86) surgery, median (IQR) Protocol Outcomes Number of admissions with contrast in cecum at 10 h (percentage)a Number of admissions with contrast in cecum at 24 h (percentage)a Complications with diatrizoate meglumine administration Imaging Number of radiographs during admission, all admissions, median (IQR) Number of radiographs during admission, nonoperative admissions, median (IQR) Number of radiographs during admission, operative admissions, median (IQR) Number of admissions with at least 1 CT during hospital stay, n (%) Number of nonoperative admissions with at least 1 CT during hospital stay, n (%)
3.6 (3.9) 3.1 (2.5)
0.12 0.56
2 (17) 37 (8)
0.04a
N/A
6 (50)
N/A
9 (75)
N/A
0
3 (3)
2.5 (2)
3 (3)
2 (1)
3 (3)
4 (2)
23 (79)
2 (17)
b.01a
10 (67)
1 (10)
.01a
CT = computed tomography. a Out of 12 eligible studies.
administered early in hospitalization for pediatric ASBO can reliably predict those who will need surgery. It is possible that this enteral contrast also functions as a nonoperative therapy, as its use is associated with a decreased rate of reoperation, decreased patient morbidity, shorter length of hospital stay, and consequently fewer costs. The safety of nonoperative management of pediatric ASBO has been previously confirmed [9]. In adults, the addition of water-soluble contrast to standard decompressive nonoperative management shortens hospital LOS and results in lower rates of surgical exploration [14]. Our data in this pediatric cohort are consistent with these findings. Further, our data suggest that pediatric patients treated with water-soluble contrast may require shorter hospital LOS as compared to adults (3.1 vs. 4 days), and may experience a lower reexploration rate (17% vs. 20.8%) [14]. Bonnard et al. are the only other group to have directly compared standard decompression vs. use of water-soluble contrast in the pediatric population [10]. They reported that hospital LOS was shorter in the water-soluble group as compared to those treated with standard decompressive therapy, finding that reexploration was necessary in 25% of the water-soluble group [10]. These intriguing observations, in combination with the significantly decreased need for surgical exploration after use of water-soluble contrast in ASBO management, suggest that there may be a therapeutic effect of water-soluble contrast in
Table 4 Costing.
Net operating cost per admission, all patients, median (IQR) Net operating cost per admission, operative patients, median (IQR) Net operating cost per admission, nonoperative patients, median (IQR) Difference in median net operating cost per admission, operative vs. nonoperative patients a
Preprotocol
Postprotocol
$16,974.07 ($16,405.38) $28,009.33a ($23,097.09)a $9237.17a ($5595.74)a $18,772.16a
$8088.65 ($13,928.90) $28,296.00 ($4507.00) $8034.50 ($4084.01) $20,261.50
Estimated, using median operating cost per day for postprotocol patients.
management of ASBO. It has been hypothesized that the relatively hyperosmolar contrast draws fluid from the bowel wall intraluminally, decreasing edema and the risk for progression of obstruction, and promoting bowel motility [15]. Our data show water-soluble contrast in ASBO management appears to be safe for a variety of adhesive-related surgical pathologies, in patients with multiple comorbidities and in those with a history of multiple previous abdominal surgeries. There are no early objective criteria to differentiate patients who will successfully respond from those who will fail nonoperative ASBO treatment. Further, surgeons are not able to consistently predict the need for surgery in such patients [16]. In contrast, enteral water-soluble contrast has been demonstrated to be a reliable diagnostic tool in predicting the need for surgery in adults [6]. This modality may be similarly reliable in the pediatric population (Table 5) [9–11]. Our data are consistent with these findings. In some cohorts of children experiencing higher rates of reoperation than adults, using water-soluble contrast as a predictive tool for surgery may decrease such iterative procedures [7,8]. In addition, this approach may promote more objective decision-making, decreasing interobserver variation during evaluation for surgical intervention. This is the first pediatric study to employ water-soluble contrast immediately upon hospital admission for ASBO. We found no increased risk of complications, and a similar rate of clinical and radiological improvement (83%) as compared to related studies that delayed administration until standard decompressive therapy of 48 h failed [11,14]. The use of water-soluble contrast early in pediatric ASBO admissions may also promote more timely surgery for those that fail nonoperative management, similar to the adult population. Earlier and more robustly predictive data can also mitigate the considerable psychological burden of ASBO on patients and families. In addition to its diagnostic capability, the use of water-soluble contrast as part of an ASBO protocol may limit radiation exposure. Our data showed that significantly fewer computed tomography was done in the postprotocol group, as well as fewer plain radiographs. Reducing the use of radiographic studies would be predicted to decrease radiation exposure, and thus the adverse effects of such exposure, especially relevant to the pediatric population [17]. ASBO requires considerable hospital resources, particularly in those patients requiring surgical management [6,18]. The reported incidence in children is from 1% to 6%, though can be as high as 25% following such procedures as ileostomy reversal [1,13,19]. In our study, almost half of all preprotocol patients underwent surgical management for ASBO. These patients had a median hospital LOS of 9.2 days (compared to 3.1 days if successfully managed nonoperatively with water-soluble contrast postprotocol) resulting in an additional $18,772.16 in net cost per admission. Use of a diagnostic protocol to predict need for surgery in ASBO may reduce this cohort size, decreasing hospital resource utilization and LOS and resulting in large cost savings. Our study was limited by the small number of patients, especially in the postprotocol group. This, combined with the varied diagnoses of the prior surgeries, did not allow for direct comparison of outcomes based on primary diagnosis of initial abdominal surgery. Management of ASBO in the preprotocol period was conducted by individual surgeons, with likely variation in radiological workup and timing of surgical intervention. Similarly, there was no standard time to initiation of the watersoluble contrast protocol for our pediatric ASBO patients, which may have led to differences in therapeutic effect. Our median time between admission and enteral contrast administration was 6.5 h (range 0–42 h) and the median time between admission and surgery for patients who failed nonoperative management was 37 h. Previous studies using enteral contrast in the pediatric population involve implementation at 48 h, after standard decompression, suggesting that the variability in time to contrast may not have affected our results. Larger patient cohorts and randomized controlled trials are needed to validate the diagnostic and therapeutic effects of water-soluble contrast in pediatric ASBO management. Further studies are also needed
Please cite this article as: Linden AF, et al, Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.002
A.F. Linden et al. / Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
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Table 5 Diagnostic role of water-soluble contrast for resolution of pediatric adhesive small bowel obstruction, literature review. Reference
n
TP
FP
FN
TN
Sensitivity (%)
Specificity (%)
PPV (%)
NPV (%)
Abdelkader, et al. 2011 [11] Bonnard A, et al. 2011 [9] Lee C, et al. 2015 [10] Study data
12 8 19 12
8 6 16 9
0 0 0 0
0 0 0 1
4 2 3 2
100 100 100 90
100 100 100 100
100 100 100 100
100 100 100 66.7
TP = true positive. FP = false positive. FN = false negative. TN = true negative.
to determine whether repeat use of water-soluble contrast for subsequent ASBO is safe and effective (as we only had two patients who underwent repeat management with water-soluble contrast), and to define its role in early pediatric ASBO (as we only had one patient undergo the protocol within 30 days of initial surgery). In conclusion enteral water-soluble contrast may play a diagnostic and therapeutic role in nonoperative management of pediatric ASBO, similar to the adult ASBO population. When administered early in hospitalization, this strategy may promote more timely decision-making, as well as decreased operative rates, hospital length of stay, and costs. This strategy warrants further multi-institutional, prospective trials with larger patient cohorts.
References [1] Grant H, Parker M, Wilson M, et al. Population-based analysis of the risk of adhesionrelated readmissions after abdominal surgery in children. J Pediatr Surg 2006;41:453–6. [2] Van der Krabben A, Dijkstra F, Nieuwenhuijzen M, et al. Morbidity and mortality of inadvertent enterotomy during adhesiolysis. Br J Surg 2000;87:467–71. [3] Assalia A, Schein M, Kopelman D, et al. Therapeutic effect of oral Gastrografin in adhesive, partial small-bowel obstruction: a prospective randomized trial. Surgery 1994;115:433–7. [4] Chen S, Chang K, Lee P, et al. Oral urografin in postoperative small bowel obstruction. World J Surg 1999;23:1051–4. [5] Abbas S, Bissett I, Parry B. Oral water soluble contrast for the management of adhesive small bowel obstruction. Cochrane Database Syst Rev 2007(3):CD004651. [6] Branco B, Barmparas G, Schnuriger B, et al. Systematic review and meta-analysis of the diagnostic and therapeutic role of water-soluble contrast agent in adhesive small bowel obstruction. Br J Surg 2010;97:470–8.
[7] Eeson G, Wales P, Murphy J. Adhesive small bowel obstruction in children: should we still operate? J Pediatr Surg 2010;45(5):969–74. [8] Ellis H, Moran B, Thompson J, et al. Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet 1999;353(9163): 1476–80. [9] Lin L, Lee C, Hung M, et al. Conservative treatment of adhesive small bowel obstruction in children: a systematic review. BMJ Open 2014;4(9):e005789. [10] Bonnard A, Kohaut J, Sieurin A, et al. Gastrografin for uncomplicated adhesive small bowel obstruction in children. Pediatr Surg Int 2011;27:1277–81. [11] Lee CY, Hung MH, Lin LH, et al. Evaluation of a water-soluble contrast agent for the conservative management of adhesive small bowel obstruction in pediatric patients. J Pediatr Surg 2014;50:581–5. [12] Abdelkader H, Abdel-Latif M, El-Asmar K, et al. Gastrografin in the management of adhesive small bowel obstruction in children: a pilot study. Ann Pediatr Surg 2011;7(1):3–6. [13] Grant H, Parker M, Wilson M, et al. Adhesions after abdominal surgery in children. J Pediatr Surg 2008;43(1):152–6. [14] Zielinski M, Haddad N, Choudhry A, et al. Multi-institutional, prospective, observational study comparing the gastrografin challenge versus standard treatment in adhesive small bowel obstruction. J Trauma Acute Care Surg 2017;83(1):47–54. [15] Choi H, Chu K, Law W. Therapeutic value of gastrografin in adhesive small bowel obstruction after unsuccessful conservative treatment: a prospective randomized trial. Ann Surg 2002;236:1–6. [16] Sarr M, Bulkley G, Zuidema G. Properative recognition of intestinal strangulation obstruction. Prospective evaluation of diagnostic capability. Am J Surg 1983;145: 176–82. [17] Chodick G, Ronckers C, Shalev V, et al. Excess lifetime cancer mortality risk attributable to radiation exposure from computed tomography examinations in children. Isr Med Assoc J 2007;9(8):584–7. [18] Ray N, Denton W, Thamer M, et al. Abdominal adhesiolysis: inpatient care and expenditures in the United States in 1994. J Am Coll Surg 1998;186:1–9. [19] Young J, Kim D, Muratore C, et al. High incidence of postoperative bowel obstruction in newborns and infants. J Pediatr Surg 2007;42(6):962–5.
Please cite this article as: Linden AF, et al, Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.002
Contents lists available at ScienceDirect
Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg
Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction☆,☆☆ Allison F. Linden a,⁎, Manish T. Raiji a, Jonathan E. Kohler b, Erica M. Carlisle c, J. Carlos Pelayo d, Kate Feinstein e, Jessica J. Kandel a, Grace Z. Mak a a
University of Chicago Medicine Comer Children's Hospital, 5841 S. Maryland Ave, MC 4062, Chicago, IL, USA 60637 University of Wisconsin School of Medicine and Public Health, 600 Highland Ave, MC 7375, Madison, WI, USA 53792 University of Iowa Children's Hospital, 200 Hawkins Drive, Iowa City, IA, USA 52242 d Children's Hospital Los Angeles, Keck School of Medicine, 4650 Sunset Blvd, Mailstop 100, Los Angeles, CA, USA 90027 e University of Chicago Medicine Comer Children's Hospital, 5841 S. Maryland Ave, MC 2026, Chicago, IL, USA 60637 b c
a r t i c l e
i n f o
Article history: Received 24 September 2018 Accepted 1 October 2018 Available online xxxx Key word: Pediatric adhesive small bowel obstruction
a b s t r a c t Background/purpose: We examined outcomes before and after implementing an enteral water-soluble contrast protocol for management of pediatric adhesive small bowel obstruction (ASBO). Methods: Medical records were reviewed retrospectively for all children admitted with ASBO between November 2010 and June 2017. Those admitted between November 2010 and October 2013 received nasogastric decompression with decision for surgery determined by surgeon judgment (preprotocol). Patients admitted after October 2013 (postprotocol) received water-soluble contrast early after admission, were monitored with serial examinations and radiographs, and underwent surgery if contrast was not visualized in the cecum by 24 h. Group outcomes were compared. Results: Twenty-six patients experienced 29 admissions preprotocol, and 11 patients experienced 12 admissions postprotocol. Thirteen (45%) patients admitted preprotocol underwent surgery, versus 2 (17%) postprotocol patients (p = 0.04). Contrast study diagnostic sensitivity as a predictor for ASBO resolution was 100%, with 90% specificity. Median overall hospital LOS trended shorter in the postprotocol group, though was not statistically significant (6.2 days (preprotocol) vs 3.6 days (postprotocol) p = 0.12). Pre- vs. postprotocol net operating cost per admission yielded a savings of $8885.42. Conclusions: Administration of water-soluble contrast after hospitalization for pediatric ASBO may play a dual diagnostic and therapeutic role in management with decreases in surgical intervention, LOS, and cost. Type of study: Retrospective comparative study. Level of evidence: Level III. © 2018 Elsevier Inc. All rights reserved.
☆ Author Contribution Study conception and design: Linden, AF; Kohler, JE; Feinstein, K; Mak, GZ. Acquisition of data: Linden, AF; Raiji, MT; Kohler, JE; Carlisle, EM; Pelayo, JC; Feinstein, K; Kandel, JJ; Mak, GZ. Analysis and interpretation of data: Linden, AF; Raiji, MT; Kohler, JE; Kandel, JJ; Mak, GZ. Drafting of manuscript: Linden, AF; Raiji, MT; Kohler, JE; Carlisle, EM; Mak, GZ. Critical revision of manuscript: Linden, AF; Raiji, MT; Kohler, JE; Carlisle, EM; Pelayo, JC; Feinstein, K; Kandel, JJ; Mak, GZ ☆☆ How this paper will improve care: Enteral water-soluble contrast can have a diagnostic as well as therapeutic role in management of pediatric adhesive small bowel obstruction. This strategy can result in decreased surgical intervention, hospital length of stay, and cost. ⁎ Corresponding author. Tel.: +1 202 903 6031. E-mail addresses: [email protected] (A.F. Linden), [email protected] (M.T. Raiji), [email protected] (J.E. Kohler), [email protected] (E.M. Carlisle), [email protected] (J.C. Pelayo), [email protected] (K. Feinstein), [email protected] (J.J. Kandel), [email protected] (G.Z. Mak).
Small bowel obstruction owing to adhesive disease is a significant contributor to postoperative morbidity in children [1]. Further, operative treatment for adhesive disease is comparatively high-risk, with as many as one third of adult patients sustaining further bowel injury during adhesiolysis procedures [2]. Thus, the availability of an effective nonoperative intervention could result in decreased patient morbidity, increased patient safety, decreased hospital length of stay, and cost savings. Enteral water-soluble contrast has been used as a successful nonoperative diagnostic and therapeutic intervention for adhesive small bowel obstruction (ASBO) in the adult population for decades [3–6]. As a diagnostic tool, enteral contrast transit from the stomach to the colon has been reported to predict nonoperative resolution of ASBO with 96% sensitivity and 98% specificity [6]. Further, patients treated using this nonoperative strategy demonstrate reduction in need for surgery and shorter time to resolution of bowel obstruction [6].
https://doi.org/10.1016/j.jpedsurg.2018.10.002 0022-3468/© 2018 Elsevier Inc. All rights reserved.
Please cite this article as: Linden AF, et al, Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.002
2
A.F. Linden et al. / Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
The effect of this intervention strategy in children with ASBO is relatively unknown, especially because intestinal obstruction may have a different pathophysiologic course. Younger children and those within their first postoperative year experience higher risks of readmission and reoperation, as compared to an increased risk of readmission over time in adults [7,8]. Despite this difference, the nonoperative approach to pediatric ASBO has been reported to be effective without increased morbidity or mortality [9]. The use of water-soluble contrast in the nonoperative treatment of pediatric ASBO has been sparsely characterized, though [10–12]. Further, these prior reports implement contrast protocols only after failure of 48 h of decompressive management. We sought to test the diagnostic and therapeutic effect of watersoluble contrast in management of pediatric ASBO by comparing outcomes before and after initiating a patient treatment protocol early in hospitalization. 1. Methods A retrospective review of medical records was performed on all children admitted with ASBO to University of Chicago Comer Children's Hospital (Chicago, IL) between November 2010 and June 2017. Records were identified based on CPT codes indicating bowel obstruction. The diagnosis of ASBO was made based on clinical and radiologic findings. Hospital cost data for all admissions between November 2013 to October 2016 were obtained. Before November 2013, patients less than 18 years of age who presented without peritonitis, clinical suspicion of strangulation or suspicion for nonadhesive small bowel obstruction were treated with nonoperative decompression. This consisted of no enteral intake, gastric decompression, and intravenous hydration. Failure of nonoperative
treatment was determined on a clinical basis by individual surgeons, at which time surgery was generally recommended. After November 2013, a clinical protocol was initiated involving administration of enteral water-soluble contrast (diatrizoate meglumine, Cystografin, Bracco Diagnostics, New Jersey, USA) for all those admitted with ASBO (Fig. 1). All pediatric surgeons at the institution adhered to the protocol. Diatrizoate meglumine was chosen owing to its lower osmolar load compared to other enteral contrast solutions, thereby minimizing fluid shifts. Inclusion criteria consisted of a history of abdominal surgery, presentation with signs of bowel obstruction (either a first episode or recurrent episode), and radiographic evidence of small bowel obstruction on computed tomography (CT) or plain radiographs. Exclusion criteria for this protocol were clinical signs of peritonitis, clinical suspicion of strangulation, known active malignancy, and known/suspicion for nonadhesive small bowel obstruction. Diatrizoate meglumine was administered as early as possible in the patient's admission or after consultation by surgery. Dosage was agedependent, with children age 8 years or older receiving 200 mL, and those under age 8 years receiving 100 mL. Contrast was administered via nasogastric tube (or gastrostomy tube if one was previously in place). The nasogastric tube was placed to suction for one hour before contrast administration. The nasogastric or gastric tube was then clamped for one hour after contrast administration. An abdominal plain radiograph was obtained at 10 h and 24 h after contrast administration. Management was considered successful if contrast had passed to the cecum by the 24 h film along with clinical improvement. If achieved, the nasogastric tube was removed and feeding was started. If contrast failed to reach the cecum after 24 h, this was deemed complete obstruction, the nonoperative strategy was considered to have failed, and surgical intervention was recommended.
Fig. 1. Flow diagram of enteral water-soluble contrast protocol.
Please cite this article as: Linden AF, et al, Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.002
A.F. Linden et al. / Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
Patient demographics, clinical history and hospital course for ASBO were abstracted for all patients. Primary outcomes assessed were percentage of ASBO resolved after diatrizoate meglumine administration, hospital length of stay (LOS) and net operating costs. Demographic and outcomes data were described as medians for quantitative variables and numbers for categorical variables. Chi square and Fisher's exact tests were used to compare categorical variables, where appropriate. Student's T-test and Mann Whitney U were used to compare continuous variables. Patients readmitted during the same time period (preprotocol or postprotocol) were counted once under patient characteristics. Each admission was treated separately when analyzing patient admission characteristics and outcomes. Statistical significance was defined as p b 0.05. Ethical approval for the retrospective review was obtained from the University of Chicago Institutional Review Board. 2. Results In the preprotocol period (November 2010 through October 2013) 26 patients experienced 29 admissions for ASBO (16 boys, 10 girls; age range 1–19 years old). In the postprotocol period (November 2013 through June 2017) 11 patients experienced 12 admissions for ASBO (10 boys, 1 girl; age range 8 months–20 years old). (Table 1). There were no significant differences in comorbidities, age at admission or other admission clinical parameters between the pre- and postprotocol groups (Table 2). In the postprotocol group, 50% of patients demonstrated contrast in the cecum at 10 h postadministration, with this group representing 60% of those ultimately able to be managed nonoperatively. Further, 90% of those children with contrast in the cecum at 24 h showed radiological and clinical improvement. One patient without contrast in the cecum at 24 h was monitored on clinical grounds for another 19 h. A repeat radiograph demonstrated contrast in the colon, concurrent with clinical improvement, and the patient did not require surgery. The sensitivity and specificity of diatrizoate meglumine as a diagnostic tool for pediatric SBO resolution were 100% and 90%, respectively. Of the 29 admissions in the preprotocol group, 13 (45%) underwent surgery (Table 3). This was significantly different than the postprotocol group, in which 2 of the 12 admissions (17%) failed to demonstrate
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Table 2 Patient characteristics on admission for small bowel obstruction.
Age (years) at admission, median (IQR) Weight (kg) at admission, median (IQR) HR on admission, median (IQR) SBP on admission, median (IQR) DBP on admission, median (IQR) WBC on admission (median)
Preprotocol
Postprotocol
p-value
14.4 (7.4) 36 (39) 104 (31) 115 73 9.0 (6.1)
11.3 (17.9) 32 (37) 89.5 (48) 117 69 9.4 (5.4)
0.69 0.35 0.75 0.52 0.56 0.23
IQR = interquartile range.
contrast in the cecum and required surgery (p = 0.04). Median overall hospital LOS trended shorter in the postprotocol group, though was not statistically significant (6.2 days (preprotocol) vs 3.6 days (postprotocol); p = 0.12). No patients were readmitted within 30 days in the postprocotol cohort. Further, median hospital LOS for nonoperative patients was slightly shorter in the postprotocol group, but not statistically significant (3.5 days (preprotocol) vs 3.1 days (postprotocol); p = 0.56). When comparing median hospital LOS from therapeutic intervention (surgery in the preprotocol group and diatrizoate meglumine administration in the post protocol group) there is a statistically significant difference between the two cohorts (6.9 vs. 2.9 days; p = 0.003). In regards to healthcare resources, postprotocol patients underwent significantly fewer CTs than preprotocol patients (79% of preprotocol patients vs. 17% of postprotocol patients, p b 0.01) (Table 3). In addition, there was a meaningful difference in estimated net operating cost per admission between pre- and postprotocol patients ($16,974.07 (preprotocol) vs. $8088.65 (postprotocol) (Table 4)). Estimated median net operating cost difference between operative and nonoperative patients was also substantial (preprotocol, estimated median net operating cost difference: $18,772.16; postprotocol, median net operating cost difference: $20,261.50). 3. Discussion Pediatric ASBO imposes significant morbidity on postoperative patients and consumes substantial healthcare resources [13]. Our data indicate that a treatment protocol utilizing water-soluble contrast
Table 1 Patient characteristics.
Total number of admissions for small bowel obstruction Number of patients Males, n (%) (per number of patients) Admissions with at least 1 comorbidity, n (%) Primary diagnosis for initial abdominal surgery Appendicitis Battery ingestion Cloaca Congenital diaphragmatic hernia Congenital mesenteric band Congenital urogenital malformation Duodenal atresia, malrotation Failure to thrive Inflammatory bowel disease Intussusception Meconium cyst Necrotizing enterocolitis Meckel's diverticulum Retroperitoneal cancer Spontaneous intestinal perforation Ovarian torsion Trauma Volvulus Unknown Number previous abdominal surgeries (median) Admissions with history of at least 2 abdominal surgeries in the past, n (%)
Preprotocol
Postprotocol
p-value
29 26 16 (62) 13 (50)
12 11 10 (91) 9 (82)
0.12 0.14
3 1 1 1 1 2 1 1 3
2
1
2 1 1 1 1
3 2 1 4 1 2 1 11 (42)
1 2 7 (64)
0.30
Please cite this article as: Linden AF, et al, Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.002
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A.F. Linden et al. / Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
Table 3 Patient outcomes. Preprotocol Postprotocol p-value Length of Stay (LOS) Overall hospital LOS (days), median (IQR) Hospital LOS for nonoperative patients (days), median (IQR)
6.2 (5.9) 3.5 (2.2)
Need for Surgery Number of admissions requiring surgery, n (%) 13 (45) Number of hours between admission and 40 (86) surgery, median (IQR) Protocol Outcomes Number of admissions with contrast in cecum at 10 h (percentage)a Number of admissions with contrast in cecum at 24 h (percentage)a Complications with diatrizoate meglumine administration Imaging Number of radiographs during admission, all admissions, median (IQR) Number of radiographs during admission, nonoperative admissions, median (IQR) Number of radiographs during admission, operative admissions, median (IQR) Number of admissions with at least 1 CT during hospital stay, n (%) Number of nonoperative admissions with at least 1 CT during hospital stay, n (%)
3.6 (3.9) 3.1 (2.5)
0.12 0.56
2 (17) 37 (8)
0.04a
N/A
6 (50)
N/A
9 (75)
N/A
0
3 (3)
2.5 (2)
3 (3)
2 (1)
3 (3)
4 (2)
23 (79)
2 (17)
b.01a
10 (67)
1 (10)
.01a
CT = computed tomography. a Out of 12 eligible studies.
administered early in hospitalization for pediatric ASBO can reliably predict those who will need surgery. It is possible that this enteral contrast also functions as a nonoperative therapy, as its use is associated with a decreased rate of reoperation, decreased patient morbidity, shorter length of hospital stay, and consequently fewer costs. The safety of nonoperative management of pediatric ASBO has been previously confirmed [9]. In adults, the addition of water-soluble contrast to standard decompressive nonoperative management shortens hospital LOS and results in lower rates of surgical exploration [14]. Our data in this pediatric cohort are consistent with these findings. Further, our data suggest that pediatric patients treated with water-soluble contrast may require shorter hospital LOS as compared to adults (3.1 vs. 4 days), and may experience a lower reexploration rate (17% vs. 20.8%) [14]. Bonnard et al. are the only other group to have directly compared standard decompression vs. use of water-soluble contrast in the pediatric population [10]. They reported that hospital LOS was shorter in the water-soluble group as compared to those treated with standard decompressive therapy, finding that reexploration was necessary in 25% of the water-soluble group [10]. These intriguing observations, in combination with the significantly decreased need for surgical exploration after use of water-soluble contrast in ASBO management, suggest that there may be a therapeutic effect of water-soluble contrast in
Table 4 Costing.
Net operating cost per admission, all patients, median (IQR) Net operating cost per admission, operative patients, median (IQR) Net operating cost per admission, nonoperative patients, median (IQR) Difference in median net operating cost per admission, operative vs. nonoperative patients a
Preprotocol
Postprotocol
$16,974.07 ($16,405.38) $28,009.33a ($23,097.09)a $9237.17a ($5595.74)a $18,772.16a
$8088.65 ($13,928.90) $28,296.00 ($4507.00) $8034.50 ($4084.01) $20,261.50
Estimated, using median operating cost per day for postprotocol patients.
management of ASBO. It has been hypothesized that the relatively hyperosmolar contrast draws fluid from the bowel wall intraluminally, decreasing edema and the risk for progression of obstruction, and promoting bowel motility [15]. Our data show water-soluble contrast in ASBO management appears to be safe for a variety of adhesive-related surgical pathologies, in patients with multiple comorbidities and in those with a history of multiple previous abdominal surgeries. There are no early objective criteria to differentiate patients who will successfully respond from those who will fail nonoperative ASBO treatment. Further, surgeons are not able to consistently predict the need for surgery in such patients [16]. In contrast, enteral water-soluble contrast has been demonstrated to be a reliable diagnostic tool in predicting the need for surgery in adults [6]. This modality may be similarly reliable in the pediatric population (Table 5) [9–11]. Our data are consistent with these findings. In some cohorts of children experiencing higher rates of reoperation than adults, using water-soluble contrast as a predictive tool for surgery may decrease such iterative procedures [7,8]. In addition, this approach may promote more objective decision-making, decreasing interobserver variation during evaluation for surgical intervention. This is the first pediatric study to employ water-soluble contrast immediately upon hospital admission for ASBO. We found no increased risk of complications, and a similar rate of clinical and radiological improvement (83%) as compared to related studies that delayed administration until standard decompressive therapy of 48 h failed [11,14]. The use of water-soluble contrast early in pediatric ASBO admissions may also promote more timely surgery for those that fail nonoperative management, similar to the adult population. Earlier and more robustly predictive data can also mitigate the considerable psychological burden of ASBO on patients and families. In addition to its diagnostic capability, the use of water-soluble contrast as part of an ASBO protocol may limit radiation exposure. Our data showed that significantly fewer computed tomography was done in the postprotocol group, as well as fewer plain radiographs. Reducing the use of radiographic studies would be predicted to decrease radiation exposure, and thus the adverse effects of such exposure, especially relevant to the pediatric population [17]. ASBO requires considerable hospital resources, particularly in those patients requiring surgical management [6,18]. The reported incidence in children is from 1% to 6%, though can be as high as 25% following such procedures as ileostomy reversal [1,13,19]. In our study, almost half of all preprotocol patients underwent surgical management for ASBO. These patients had a median hospital LOS of 9.2 days (compared to 3.1 days if successfully managed nonoperatively with water-soluble contrast postprotocol) resulting in an additional $18,772.16 in net cost per admission. Use of a diagnostic protocol to predict need for surgery in ASBO may reduce this cohort size, decreasing hospital resource utilization and LOS and resulting in large cost savings. Our study was limited by the small number of patients, especially in the postprotocol group. This, combined with the varied diagnoses of the prior surgeries, did not allow for direct comparison of outcomes based on primary diagnosis of initial abdominal surgery. Management of ASBO in the preprotocol period was conducted by individual surgeons, with likely variation in radiological workup and timing of surgical intervention. Similarly, there was no standard time to initiation of the watersoluble contrast protocol for our pediatric ASBO patients, which may have led to differences in therapeutic effect. Our median time between admission and enteral contrast administration was 6.5 h (range 0–42 h) and the median time between admission and surgery for patients who failed nonoperative management was 37 h. Previous studies using enteral contrast in the pediatric population involve implementation at 48 h, after standard decompression, suggesting that the variability in time to contrast may not have affected our results. Larger patient cohorts and randomized controlled trials are needed to validate the diagnostic and therapeutic effects of water-soluble contrast in pediatric ASBO management. Further studies are also needed
Please cite this article as: Linden AF, et al, Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.002
A.F. Linden et al. / Journal of Pediatric Surgery xxx (xxxx) xxx–xxx
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Table 5 Diagnostic role of water-soluble contrast for resolution of pediatric adhesive small bowel obstruction, literature review. Reference
n
TP
FP
FN
TN
Sensitivity (%)
Specificity (%)
PPV (%)
NPV (%)
Abdelkader, et al. 2011 [11] Bonnard A, et al. 2011 [9] Lee C, et al. 2015 [10] Study data
12 8 19 12
8 6 16 9
0 0 0 0
0 0 0 1
4 2 3 2
100 100 100 90
100 100 100 100
100 100 100 100
100 100 100 66.7
TP = true positive. FP = false positive. FN = false negative. TN = true negative.
to determine whether repeat use of water-soluble contrast for subsequent ASBO is safe and effective (as we only had two patients who underwent repeat management with water-soluble contrast), and to define its role in early pediatric ASBO (as we only had one patient undergo the protocol within 30 days of initial surgery). In conclusion enteral water-soluble contrast may play a diagnostic and therapeutic role in nonoperative management of pediatric ASBO, similar to the adult ASBO population. When administered early in hospitalization, this strategy may promote more timely decision-making, as well as decreased operative rates, hospital length of stay, and costs. This strategy warrants further multi-institutional, prospective trials with larger patient cohorts.
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Please cite this article as: Linden AF, et al, Evaluation of a water-soluble contrast protocol for nonoperative management of pediatric adhesive small bowel obstruction, J Pediatr Surg (2018), https://doi.org/10.1016/j.jpedsurg.2018.10.002