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

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Trial Identification

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

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

Study ID: NCT05546892

Conditions

Colon Cancer

Interventions

Full bowel preparation prior to colon resection for cancer

No bowel preparation

Study Description

Brief 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.