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

Subtotal Colectomy Clinical Trial

— RIALTCOT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04512326
• Other study ID #: 212/20
• Status: Enrolling by invitation
• Start date: August 10, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: August 2020
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: November 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Subtotal Colectomy
• Total Colectomy

Intervention

Procedure:
• Total or Subtotal colectomy
Total or subtotal colectomy (emergent or elective) with primary anastomosis (ileorectal or ileosigmoid)

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (15)

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):606-6 — View Citation

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. — View Citation

Björk J, Akerbrant H, Iselius L, Svenberg T, Oresland T, Påhlman 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):98 — View Citation

Duclos J, Lefevre JH, Lefrançois 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. d — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. Review. — View Citation

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/S — View Citation

Moszkowicz D, Mariani A, Trésallet 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Risk factors associated to postoperative morbidity	Morbidity by Clavien-Dindo scale	90 days postoperatively
Secondary	Risk factors associated to mortality	Mortality in postoperatively	90 days postoperatively
Secondary	Risk factors associated to re-admissions.	Re-admissions after discharge within 90 days postoperatively	90 days postoperatively