Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rectal Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 sta...
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.
Tracking Information
- NCT #
- NCT04592289
- Collaborators
- Not Provided
- Investigators
- Study Chair: Aleksei Karachun National Medical Research Centre of Oncology named after N.N. Petrov
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