drugset / Trial / NCT03475680

Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery

NCT03475680

Phase 3 Terminated 193 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupDouble-blindPrevention

Summary

This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation. Our Hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

Timeline

Start
2018-08-08
Primary completion
2021-08-26
Completion
2022-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Gentamicin Small molecule 80 mg Oral
Subject Ornidazole Other / unclassified 1 g Oral
Subject Sennosides Unknown

Indications