Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone (REPCA)

  • STATUS
    Recruiting
  • End date
    Aug 22, 2023
  • participants needed
    622
  • sponsor
    N.N. Petrov National Medical Research Center of Oncology
Updated on 22 September 2022
adenocarcinoma
proctectomy

Summary

The purpose of the study is to determine if short-term outcomes of rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.

Description

The design involves random allocation of eligible patients to full bowel preparation or only mechanical bowel preparation in 1:1 ratio. After that rectal 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 surgical site infection is anticipated to decrease from 12% (data from local registry) to 6%. For power of 80% enrolment of 622 patients is required.

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

Details
Condition Rectal Cancer
Treatment Full bowel preparation, Mechanical bowel preparation only
Clinical Study IdentifierNCT04592289
SponsorN.N. Petrov National Medical Research Center of Oncology
Last Modified on22 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

histologically confirmed adenocarcinoma of the rectum or rectosigmoid junction
clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)
indications for surgical rectal 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 obstructive resection or abdominoperineal excision
Acute bowel obstruction, bleeding or perforation
Other malignancies not in remission
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