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

• ClinicalTrials.gov Identifier: NCT04512326
• Recruitment Status: Unknown
• First Posted: August 13, 2020
• Last Update Posted: August 13, 2020
• Sponsor: Hospital Universitario Ramon y Cajal
• Information provided by (Responsible Party): Juan Ocaña Jiménez, Hospital Universitario Ramon y Cajal

Study Description

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.

Condition or disease	Intervention/treatment
Total Colectomy; Subtotal Colectomy	Procedure: Total or Subtotal colectomy

Detailed Description:

Ileorectal (IRA) or ileosigmoid anastomosis (ISA) following Total or Subtotal Colectomy (TSC) are frequently performed in inflammatory bowel disease (IBD) (Crohn´s disease, ulcerative colitis and indeterminate colitis), familiar adenomatous polyposis or colonic polyposis syndromes and colorectal cancer (CRC). TSC is less frequently performed in refractory constipation and ischemic colitis.

Anastomotic leakage (AL) is a significant complication associate with increased mortality, reoperation and derivative morbidity and is also related to poor long term outcomes in oncological resections. Although, the formation of IRA or ISA is anatomically easy to performed, pelvic dissection is not mandatory, there is no tension at the anastomosis and a blood supply is theoretically ensured, higher AL risk is reported after IRA or ISA (6.5-21%) compared to colonic or colorectal anastomosis with lower AL rate, mainly under 15%. Regardless of the indication, similar AL rates are seen after TSC in IBD (4-12%), polyposis (20%) and colon cancer (6-21%). Reducing AL rates might improve short, long term and functional outcomes after IRA or ISA There is not a wide evidence about determinants for AL following colectomy with IRA or ISA.

The impact of the anastomosis (ISA or ISA) on AL is controversial with no findings any in the most recent studies. Great number of studies have been published about risk factors for AL after colectomy, but the majority are focused in colorectal cancer patients. IRA or ISA results after TSC are mixed with other anastomosis sites and the reported results are hardly clear and conclusive.

For this reason, The investigators aim to assess potential risk factors to AL in restorative TSC, including every surgical main reason.

Study Design

• Study Type: Observational
• Estimated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: RISK FACTORS FOR ANASTOMOTIC LEAKAGE FOLLOWING TOTAL OR SUBTOTAL COLECTOMY (RIALTCOT)
• Actual Study Start Date: August 10, 2020
• Estimated Primary Completion Date: June 30, 2021
• Estimated Study Completion Date: November 30, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Total or subtotal colectomy; Total or subtotal colectomy with ileorectal or ileosigmoid anastomosis	Procedure: Total or Subtotal colectomy; Total or subtotal colectomy (emergent or elective) with primary anastomosis (ileorectal or ileosigmoid)

Outcome Measures

Primary Outcome Measures :

1. Anastomotic Leakage [ Time Frame: 90 days postoperatively ]
   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

Secondary Outcome Measures :

1. Risk factors associated to postoperative morbidity [ Time Frame: 90 days postoperatively ]
   Morbidity by Clavien-Dindo scale
2. Risk factors associated to mortality [ Time Frame: 90 days postoperatively ]
   Mortality in postoperatively
3. Risk factors associated to re-admissions. [ Time Frame: 90 days postoperatively ]
   Re-admissions after discharge within 90 days postoperatively

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients underwent total or subtotal colectomy with primary anastomosis

Criteria

Inclusion Criteria:

• (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

Exclusion Criteria:

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

Contacts and Locations

Locations

Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Sponsors and Collaborators

Hospital Universitario Ramon y Cajal

Investigators

• Principal Investigator: Juan Ocaña, MD; H.U Ramon y Cajal

More Information

Publications of Results:

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Other Publications:

Elton C, Makin G, Hitos K, Cohen CR. Mortality, morbidity and functional outcome after ileorectal anastomosis. Br J Surg. 2003 Jan;90(1):59-65. doi: 10.1002/bjs.4005.

• Responsible Party: Juan Ocaña Jiménez, Principal Investigator, Hospital Universitario Ramon y Cajal
• ClinicalTrials.gov Identifier: NCT04512326
• Other Study ID Numbers: 212/20
• First Posted: August 13, 2020
• Last Update Posted: August 13, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juan Ocaña Jiménez, Hospital Universitario Ramon y Cajal:

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

Additional relevant MeSH terms:

Anastomotic Leak; Postoperative Complications; Pathologic Processes