Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Resections for Cancer Versus no Bowel Preparation (COLRABI)

  • STATUS
    Recruiting
  • End date
    Sep 17, 2025
  • participants needed
    586
  • sponsor
    N.N. Petrov National Medical Research Center of Oncology
Updated on 17 October 2022

Summary

The purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.

Description

The design involves random allocation of eligible patients to full bowel preparation or no bowel preparation in 1:1 ratio. After that colon resection is performed in both groups.

Short-term outcomes are assessed in 30 day period after surgery. This is a superiority trial evaluating statistical superiority. Rate of anastomotic leak is anticipated to decrease from 8% (data from local registry) to 3%. For power of 80% enrolment of 586 patients is required.

The intent-to-treat principle is used for the data analysis.

Details
Condition Colon Cancer
Treatment Full bowel preparation prior to colon resection for cancer, No bowel preparation
Clinical Study IdentifierNCT05546892
SponsorN.N. Petrov National Medical Research Center of Oncology
Last Modified on17 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid)
clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
indications for surgical colonic resection
ECOG status 0-2
At least 18 years of age
Written informed consent

Exclusion Criteria

Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
Pregnancy or breast feeding
Medical contraindications for surgical treatment
Any use of antibiotics 30 days prior to inclusion
Functioning stoma
Contraindications for use of MBP or OA drugs or their components
Indications for mandatory MBP (planned intraoperative colonoscopy etc)
Indications for obstructive resection
Acute bowel obstruction, bleeding or perforation
Other malignancies not in remission
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