NCT05546892

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 586 (estimated)
• Sponsor: N.N. Petrov National Medical Research Center of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
PROCEDURE	Full bowel preparation prior to colon resection for cancer	Mechanical bowel preparation and oral antibiotics
PROCEDURE	No bowel preparation	Omission of any bowel preparation

Timeline

• Start date: 2023-02-10
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-09-21
• Last updated: 2023-03-29

Locations

1 site across 1 country: Russia