Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Rectal Resections for Cancer Versus MBP Alone (REPCA)
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- STATUS
- Recruiting
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- End date
- Aug 18, 2023
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- participants needed
- 622
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- sponsor
- N.N. Petrov National Medical Research Center of Oncology
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 Identifier | NCT04592289 |
| Sponsor | N.N. Petrov National Medical Research Center of Oncology |
| Last Modified on | 18 October 2022 |
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