1、 1 Surgery or stenting for colonic obstruction: a practice management guideline from the eastern association for the surgery of trauma Paula Ferrada MD1; Mayur Patel, MD, MPH2; Vitaliy Y. Poylin, MD3; Brandon Bruns, MD4; Stefan Leichtle, MD5; Salina Wydo, MD6; Shahnaz Sultan, MD7; Elliott Haut, MD,
2、PhD8; Bryce Robinson MD, MS, FACS, FCCM9 1Virginia Commonwealth University, Richmond VA 2Vanderbilt University Medical Center, Nashville, TN 3Beth Israel Deaconess Medical Center, Boston MA 4University of Maryland, Baltimore, MD 5LAC+USC Medical Center, Los Angeles, CA 6Cooper University Hospital in
3、 Philadelphia, PA 7University of Florida, Gainesville FL 8The Johns Hopkins University Bloomberg School of Public Health 9University of Washington, Harborview Medical Center Seattle, WA Submitted: December 11, 2015, Accepted: December 16, 2015. Corresponding Author: Paula Ferrada MD FACS 1 VCU Surge
4、ry Trauma, Critical Care and Emergency Surgery Email: pferradamcvh-vcu.edu Mailing Address: PO Box 980454. Richmond, VA 23298-0454 Journal of Trauma and Acute Care Surgery, Publish Ahead of PrintDOI: 10.1097/TA.0000000000000966Copyright 2016 Wolters Kluwer Health, Inc. All rights 2 Richmond, VA 2329
5、8 Copyright 2016 Wolters Kluwer Health, Inc. All rights reserved.Location/Delivery Address: West Hospital, 15th Floor, East Wing 1200 E. Broad St. 3 ABSTRACT Introduction: Colonic obstruction is a surgical emergency and delay in decompression results in added morbidity and mortality. Advances have l
6、ed to less invasive procedures such as stenting as a bridge for definitive surgery. The aim of this manuscript is to perform a systematic review regarding colon obstruction (malignant or benign) and to provide recommendations following the GRADE framework. Methods: A systematic literature review was
7、 conducted using the using the PubMed, Embase, and the Cochrane Library databases for published studies. The search was last performed on January 2, 2015. Two independent reviewers extracted the desired variables from the studies. For our meta-analysis, we used Review Manager X.6 (RevMan). Recommend
8、ations are provided using GRADE methodology. A single population, intervention, comparator, outcome (PICO) question with two outcomes was addressed: Population: In adult patients with a colonic obstruction (malignant or benign) Intervention: should surgery be performed Comparator: vs. endoscopic ste
9、nting Outcomes: decreased mortality and decreased emergency, non-planned procedures? Results: The search yielded to 210 results. Screening of the titles excluded 102 articles, leaving 108 for review. After abstract review, 71 additional papers were excluded due to failure to address the PICO questio
10、ns of this guideline. Thirty-seven articles were reviewed in their entirety, of those 6 randomized control trials that evaluated the use of stents versus emergency surgery in colonic obstruction due to malignant disease were included in the final qualitative review Copyright 2016 Wolters Kluwer Heal
11、th, Inc. All rights 4 Recommendations: We conditionally recommend endoscopic, colonic stenting (if available) as initial therapy for colonic obstruction. In our review, stent use was associated with decrease mortality and rates for emergency, non-planned procedures to include reoperations. This cond
12、itional recommendation is limited to those with malignancy due to the lack of literature supporting this practice in benign colonic disease. Level of Evidence: Systematic Review of only randomized controlled trials. Level 1 Copyright 2016 Wolters Kluwer Health, Inc. All rights 5 BACKGROUND Colonic o
13、bstruction is a surgical emergency since delay in decompression is associated with increased morbidity and mortality 1, 2. Although more commonly caused by cancer, it can present as a consequence of benign disease, such as diverticulitis, volvulus, bezoars, or hernias 3. Although recently technical
14、advances have resulted in the placement of endoscopic stents as an option for the treatment of colonic obstruction; controversy in the matter still exist 3, 4. The aim of this manuscript is to perform a systematic review with associated meta-analyses so to create a guideline that may be used to dire
15、ct decision-making in the care of patients with colonic obstruction. This guideline was overseen by the Practice Management Guideline Section of the Eastern Association for the Surgery of Trauma (EAST) using a framework established by the Grading of Recommendations Assessment, Development and Evalua
16、tion (GRADE) Working Group.5-7 OBJECTIVES Our Population, Intervention, Comparator, and Outcome (PICO) questions are defined below: Population: Initial therapy in adult patients with colonic obstruction (malignant or benign) Intervention: Surgery Comparator: Endoscopic stenting Outcomes: Mortality a
17、nd complications resulting in emergency unplanned procedure Copyright 2016 Wolters Kluwer Health, Inc. All rights 6 PICO #1: In adult patients with colonic obstruction (malignant or benign) (P) should surgery (I) or endoscopic stenting (C) be performed to decrease mortality (O)? PICO#2: In adult pat
18、ients with colonic obstruction (malignant or benign) (P) should surgery (I) or endoscopic stenting (C) be performed to decrease emergency, non-planned procedures (O)? METHODS Study Eligibility Inclusion criteria consisted of articles published in the English language reporting adult patients 18 year
19、s or older, who required hospitalization for management of colonic obstruction with surgery or endoscopic stenting. We excluded meta-analyses, case reports, letters, and reviews lacking original data. Intervention and Comparators We only included studies directly comparing stenting to emergency, non
20、-planned surgery. Critical Outcome As per GRADE methodology, outcomes were chosen by the team and rated in importance from 1 to 9, with scores of 7 to 9 representing critical outcomes after intervention for colonic obstruction. The critical outcome was mortality, rated a score of 9. Copyright 2016 W
21、olters Kluwer Health, Inc. All rights 7 Secondary Outcome Emergency, non-planned procedures were selected as a secondary outcome due to a rated score of 7 Other outcomes considered but excluded were renal failure, length of stay, and hospital cost due to ratings 7. Information Sources Two profession
22、al librarians conducted a systematic search using the PubMed, Embase, and the Cochrane Library databases published studies. The search was last run on January 2nd of 2015 and used the following Medical Subject Headings (MESH) terms: (StentsMesh OR stent*tiab) OR (surgerytiab OR surgical*tiab OR surg
23、ery Subheading:NoExp OR Digestive System Surgical ProceduresMesh) AND (ColonMajr OR colontiab OR colonictiab) AND (Intestinal ObstructionMesh:NoExp OR obstruct*tiab) AND (mortality Subheading OR mortalitytiab OR death*tiab OR survivaltiab) AND (Comparative Study Publication Type OR compare*tiab OR c
24、ompari*tiab). In addition to the electronic search, we hand-searched the bibliographies of recent reviews and papers accepted for this study, as well as reviewed the ClinicalTrials.gov registry. All studies found from 1990 until the last date of the search were considered. Last search was performed
25、January of 2015. Selection of Studies After completing the electronic literature search, two independent reviewers screened titles and abstracts, applying the a priori PICO inclusion criteria. Any disagreement on inclusion was resolved by consensus. The resulting studies then underwent full text rev
26、iew, again by two independent reviewers, to determine appropriateness for inclusion. Copyright 2016 Wolters Kluwer Health, Inc. All rights 8 Data Extraction and Management Two independent reviewers extracted the desired variables from the studies into Microsoft Excel. For two meta-analyses, we used
27、Review Manager X.6 (RevMan a program developed for The Cochrane Collaboration to assist authors in preparing Cochrane reviews for publication in The Cochrane Database of Systematic Reviews.) Measures of Treatment Effect We reported the dichotomous outcomes of mortality and need for emergency, non-pl
28、anned operation as an odds ratio (OR), with associated 95% confidence intervals (CI) and p-values. The unit of analysis was individual patients. Assessment of Heterogeneity Potential heterogeneity exists due to population differences, different types of surgery performed, and how obstruction were de
29、fined. We examined these differences across studies to assess the clinical and methodological heterogeneity. For the meta-analyses, we used RevMan to calculate the Q statistic, and then the I2 statistic (%) was used to determine the proportion of variation between studies attributable to heterogenei
30、ty, and categorized as low (25-49%), moderate (50-74%), or high (74-100%). We also used the Chi-square test for heterogeneity and examined the confidence intervals for overlap, with decreasing overlap representing increasing heterogeneity. If heterogeneity was moderate to high, we did not consider p
31、ooling the data to be appropriate, and we performed a qualitative narrative summary of results. Based on the methodologic and clinical similarity, we performed meta-analysis for each outcome. Copyright 2016 Wolters Kluwer Health, Inc. All rights 9 RESULTS Qualitative Analysis Initially, the search y
32、ielded to 210 studies. Title only review excluded 102 articles. Abstract review excluded another 71 articles, leaving 37 articles for full text review. Of those 37 articles, 6 were randomized controlled trials (RCTs). These RCTs were included in the final qualitative review. 8-13 (Figure 1 CONSERT d
33、iaphragm) . We were unable to find literature that addressed stent use in benign disease; however, we included two articles focusing on benign disease for the qualitative review 3, 14. Four randomized clinical trials (RCT) compared mortality between the two interventions, representing a total of 206
34、 patients, where 94 were treated with operation and 112 were treated with endoscopic stenting. None of the articles addressed timing of intervention or benign disease indications. Finally, we identified four studies that were appropriate for quantitative synthesis for PICO question #18, 11-13, and t
35、wo studies for PICO question #28, 11. (Figure 2) Results obtained for PICO question #1 PICO #1: In adult patients with colonic obstruction (malignant or benign) (P) should surgery (I) or endoscopic stenting (C) be performed to decrease mortality (O)? Our search yielded to no results addressing morta
36、lity regarding the use of stents versus emergency, non-planned surgery for benign disease. Four RTC compared mortality between the two interventions.8, 11-13 Alcantra et al 8shown no statistically significant difference in mortality between the two groups, in his trial there were no deaths in the st
37、ent group and one death in the patients that received emergency Copyright 2016 Wolters Kluwer Health, Inc. All rights 10 surgery8, however this was a small sample (stent=15, surgery =13). Van Hooft 13 et al had a larger sample size ( stent= 47 versus surgery= 51) without a difference in mortality be
38、ing detected (30 day mortality; 5 patients in each group). Ho 11 et al reported an 18% increase in mortality in the emergency surgery group (3 patients died in the surgery group versus none in the patients that received a stent). Prilet et al 12 et al reported four in-hospital deaths during their .
39、One patient in the surgery group died the same day of surgery as a consequence of end organ failure, and three patients died in the stent group as a result of the procedure (1 from rapid progression of his neoplastic illness, 1 from mesenteric infarction, and 1 from septic shock and multi-visceral f
40、ailure after anastomotic leakage). A total of 32 patients underwent emergency surgery and 35 received a stent in this trial. In all the RTC, implicit is that colonic obstruction is a surgical emergency that requires prompt treatment and decompression. None of the articles addressed increased mortali
41、ty by delayed therapy, either in stenting or emergency, non-planned surgery since prompt treatment before perforation is considered in all studies as the standard of care. Quantitative Analysis (Meta-analysis) Comparisons between the use of stents and emergency, non-planned surgery evaluating mortal
42、ity as an outcome were found in four RCT. Analysis of the pooled data revealed that colonic stenting achieved significantly lower mortality rates than emergency, un-planned surgery. (Figure 2). However, a mild amount of heterogeneity was found (I2 = 17 % ). Results obtained for PICO question #2 In a
43、dult patients with colonic obstruction (malignant or benign) (P) should surgery (I) or endoscopic stenting (C) be performed to decrease emergency, non-planned procedures (O)? Copyright 2016 Wolters Kluwer Health, Inc. All rights 11 Qualitative Analysis Regarding benign disease, two articles mentione
44、d morbidity after stenting or surgery 3, 14. Kohel et al14 describes his experience with stenting strictures secondary to inflammatory bowel disease; however without mentioning strictures for diverticulitis. Immediate surgery was required in three patients secondary to perforation with stent placeme
45、nt, 11 patients had elective surgery after stent placement due to stent dislocation, or recurrent stenosis, and six patients had successful placement without need for surgery.14 This manuscript describes a series of 14 patients with anastomotic stricture of which nine have long-term cure with stenti
46、ng. This article does not compare emergency, non-planned surgery versus stenting for begin disease, but merely describes the authors experience with stenting. Small et al 3 describes successful stent placement in 23 patients with benign disease. In this series, complications occurred in 38% of the p
47、atients including migration (n = 2), re-obstruction (n = 4), and perforation (n = 2). Of these major complications, 87% occurred after seven days. Fifteen of these patients had diverticulitis as the main reason for obstruction, two patients had strictures secondary to radiation, three patients had a
48、nastomotic strictures, two had an inflammatory stricture (etiology unknown) and one patient had Crohns disease. This paper also fails to compare emergency, non-planned surgery with stents. Two RTC compare emergency, non-planned procedures or reoperation in patients with acute colonic obstruction, bu
49、t only include malignant disease 8, 11. Alcantara8 et al shows a statistically significant difference between the stent and emergency surgery group, favoring stent placement (reoperation stent = 0 of 15, emergency surgery= 4 of 13). While Ho 11 fails to support this finding (stent = 2 of 20, versus emergency surgery 2 of 19). However in this study, overall complication rates were higher in the emergency surgery group (stent= 305 versus emergency surgery 58%). All RTC assumed that colonic obstruction is a surgical emergency that requires prompt treatment. None of the articles addresse
