RISK FACTORS FOR ANASTOMOTIC LEAKAGE FOLLOWING TOTAL OR SUBTOTAL COLECTOMY (RIALTCOT)

NCT04512326 | Unknown

• 1 other identifier: 212/20
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Higher anastomotic leakage (AL) rate is reported after ileosigmoid (ISA) or ileorectal anastomosis (IRA) in total or subtotal colectomy (TSC) compared to colonic or colorectal anastomosis. An AL reduction in these cases may improve short and long terms outcomes significantly. Current evidence remains insufficient to assess AL risk after TSC, based on single-center studies or small cases series. The investigators aim to analyse and identify potential risk factors to AL following TSC and ISA or IRA, both preoperative and intraoperative in order to prevent surgical complications. The study is set up as a retrospective multicentre observational study. Inclusion criteria are patients (1) over 18 years old, (2) underwent restorative TSC with ISA or IRA anastomosis, (3) with/without loop ileostomy (4) between 2013-2019. Exclusion criteria are: (1) non-restorative TSC, (2) previous colorectal resection, (3) deferred anastomosis in trauma surgery and (4) other surgical resection in the same procedure. AL will be defined as a defect of the integrity of the intestinal wall at the anastomotic site leading to a communication of the intra and extraluminal or a pelvic abscess adjacent to the anastomosis according to the definition set by de International Study Group of Rectal Cancer. AL requiring no active therapeutic intervention will be classified as Grade A. AL requiring active therapeutic intervention (antibiotics and percutaneous drainage) but manageable without relaparotomy will be classified as Grade B and AL requiring re-intervention were classified as Grade C. Multivariable logistic regression model will be used in order to assess potential AL risk factors. p value \<0,05 will be consider to indicate statistical significance. Primary outcome is to assess potential risk factors to AL after restorative (ISA or IRA) TSC. Secondary outcomes are to identify risk factors to associated postoperative morbidity, mortality and re-admissions. Data will be collected in each participating center enrolled in the study by the assigned principal investigator, confidentially and codified. Data will be sent to the study principal investigator. Database, patients code and email address will be provided at the study inclusion.

Conditions

Total Colectomy; Subtotal Colectomy

Keywords

Total colectomy; Subtotal colectomy; Ileorectal anastomosis; Ileosigmoid anastomosis; Anastomotic leakage

Outcome Measures

Primary Outcomes (1)

• Anastomotic Leakage

  AL requiring no active therapeutic intervention will be classified as Grade A. AL requiring active therapeutic intervention (antibiotics and percutaneous drainage) but manageable without relaparotomy will be classified as Grade B and AL requiring re-intervention will be classified as Grade C

  90 days postoperatively

Secondary Outcomes (3)

• Risk factors associated to postoperative morbidity

  90 days postoperatively

• Risk factors associated to mortality

  90 days postoperatively

• Risk factors associated to re-admissions.

  90 days postoperatively

Study Arms (1)

Total or subtotal colectomy

Total or subtotal colectomy with ileorectal or ileosigmoid anastomosis

Procedure: Total or Subtotal colectomy

Interventions

Total or Subtotal colectomy PROCEDURE

Total or subtotal colectomy (emergent or elective) with primary anastomosis (ileorectal or ileosigmoid)

Total or subtotal colectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients underwent total or subtotal colectomy with primary anastomosis

You may qualify if:

• (1) over 18 years old
• (2) underwent restorative TSC with ISA or IRA anastomosis (emergent or elective)
• (3) with/without loop ileostomy
• (4) between 2013-2019

You may not qualify if:

• (1) non-restorative TSC
• (2) previous colorectal resection
• (3) deferred anastomosis in trauma surgery and
• (4) other surgical resection in the same procedure.

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Related Publications (15)

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  PMID: 12520576 BACKGROUND

• Moszkowicz D, Mariani A, Tresallet C, Menegaux F. Ischemic colitis: the ABCs of diagnosis and surgical management. J Visc Surg. 2013 Feb;150(1):19-28. doi: 10.1016/j.jviscsurg.2013.01.002. Epub 2013 Feb 20.

  PMID: 23433833 RESULT

• Washington C, Carmichael JC. Management of ischemic colitis. Clin Colon Rectal Surg. 2012 Dec;25(4):228-35. doi: 10.1055/s-0032-1329534.

  PMID: 24294125 RESULT

• Bakker IS, Grossmann I, Henneman D, Havenga K, Wiggers T. Risk factors for anastomotic leakage and leak-related mortality after colonic cancer surgery in a nationwide audit. Br J Surg. 2014 Mar;101(4):424-32; discussion 432. doi: 10.1002/bjs.9395.

  PMID: 24536013 RESULT

• Mirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929.

  PMID: 21394013 RESULT

• Law WL, Choi HK, Lee YM, Ho JW, Seto CL. Anastomotic leakage is associated with poor long-term outcome in patients after curative colorectal resection for malignancy. J Gastrointest Surg. 2007 Jan;11(1):8-15. doi: 10.1007/s11605-006-0049-z.

  PMID: 17390180 RESULT

• Lu ZR, Rajendran N, Lynch AC, Heriot AG, Warrier SK. Anastomotic Leaks After Restorative Resections for Rectal Cancer Compromise Cancer Outcomes and Survival. Dis Colon Rectum. 2016 Mar;59(3):236-44. doi: 10.1097/DCR.0000000000000554.

  PMID: 26855399 RESULT

• Duclos J, Lefevre JH, Lefrancois M, Lupinacci R, Shields C, Chafai N, Tiret E, Parc Y. Immediate outcome, long-term function and quality of life after extended colectomy with ileorectal or ileosigmoid anastomosis. Colorectal Dis. 2014 Aug;16(8):O288-96. doi: 10.1111/codi.12558.

  PMID: 24428330 RESULT

• 2015 European Society of Coloproctology Collaborating Group. Predictors for Anastomotic Leak, Postoperative Complications, and Mortality After Right Colectomy for Cancer: Results From an International Snapshot Audit. Dis Colon Rectum. 2020 May;63(5):606-618. doi: 10.1097/DCR.0000000000001590.

  PMID: 32032201 RESULT

• Platell C, Mackay J, Woods R. A multivariate analysis of risk factors associated with recurrence following surgery for Crohn's disease. Colorectal Dis. 2001 Mar;3(2):100-6. doi: 10.1046/j.1463-1318.2001.00213.x.

  PMID: 12791002 RESULT

• Nakamura T, Pikarsky AJ, Potenti FM, Lau CW, Weiss EG, Nogueras JJ, Wexner SD. Are complications of subtotal colectomy with ileorectal anastomosis related to the original disease? Am Surg. 2001 May;67(5):417-20.

  PMID: 11379639 RESULT

• Pastore RL, Wolff BG, Hodge D. Total abdominal colectomy and ileorectal anastomosis for inflammatory bowel disease. Dis Colon Rectum. 1997 Dec;40(12):1455-64. doi: 10.1007/BF02070712.

  PMID: 9407985 RESULT

• Loftus EV Jr, Delgado DJ, Friedman HS, Sandborn WJ. Colectomy and the incidence of postsurgical complications among ulcerative colitis patients with private health insurance in the United States. Am J Gastroenterol. 2008 Jul;103(7):1737-45. doi: 10.1111/j.1572-0241.2008.01867.x. Epub 2008 Jun 28.

  PMID: 18564126 RESULT

• Bjork J, Akerbrant H, Iselius L, Svenberg T, Oresland T, Pahlman L, Hultcrantz R. Outcome of primary and secondary ileal pouch-anal anastomosis and ileorectal anastomosis in patients with familial adenomatous polyposis. Dis Colon Rectum. 2001 Jul;44(7):984-92. doi: 10.1007/BF02235487.

  PMID: 11496079 RESULT

• Segelman J, Mattsson I, Jung B, Nilsson PJ, Palmer G, Buchli C. Risk factors for anastomotic leakage following ileosigmoid or ileorectal anastomosis. Colorectal Dis. 2018 Apr;20(4):304-311. doi: 10.1111/codi.13938.

  PMID: 29059489 RESULT

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Ocaña, MD

  H.U Ramon y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 13, 2020
• Study Start: August 10, 2020
• Primary Completion: June 30, 2021
• Study Completion: November 30, 2021
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

ES (1)