NCT04592289

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 622 (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 rectal resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to rectal resections with only mechanical bowel preparation.

Detailed 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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Full bowel preparation	MBP+OA
PROCEDURE	Mechanical bowel preparation only	MBP

Timeline

• Start date: 2020-10-30
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2020-10-19
• Last updated: 2023-11-18

Locations

7 sites across 1 country: Russia