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

NCT04512326 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2020-08-13

No results posted yet for this study

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

Interventions

PROCEDURE

Total or Subtotal colectomy

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

Sponsors & Collaborators

  • Hospital Universitario Ramon y Cajal

    lead OTHER

Principal Investigators

  • Juan Ocaña, MD · H.U Ramon y Cajal

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2021-06-30
Completion
2021-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04512326 on ClinicalTrials.gov