Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Resections for Cancer Versus no Bowel Preparation (COLRABI)
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- STATUS
- Recruiting
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- End date
- Sep 17, 2025
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- participants needed
- 586
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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 colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.
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.
Details
| Condition | Colon Cancer |
|---|---|
| Treatment | Full bowel preparation prior to colon resection for cancer, No bowel preparation |
| Clinical Study Identifier | NCT05546892 |
| Sponsor | N.N. Petrov National Medical Research Center of Oncology |
| Last Modified on | 17 October 2022 |
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