drugset / Trial / NCT03491540

Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery

NCT03491540

Phase 3 Completed 414 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 rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone Our hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone

Timeline

Start
2018-09-03
Primary completion
2023-10-23
Completion
2023-12-12

Drugs

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

Indications