drugset / Trial / NCT04161599

Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.

NCT04161599

RandomizedParallel-groupSingle-blindPrevention

Summary

The ORALEV Study found that preoperative oral antibiotics can reduce the incidence of surgical site infections after colonic resection, compared with no preparation. The role of mechanical bowel preparation in patients needing colonic surgery is yet to be elucidated. No randomised controlled trials have assessed the impact of mechanical bowel preparation combined with oral antibiotics on the incidence of surgical site infections after colonic surgery, compared with oral antibiotics only.

Timeline

Start
2022-03-01
Primary completion
2024-06
Completion
2024-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Magnesium Oxide Small molecule 3.5 g Oral
Subject Sodium Picosulfate Unknown 10 mg Oral
Subject citric acid Unknown 10.97 g Oral
Background Cefuroxime Small molecule 750 mg Intravenous
Background Cefuroxime Small molecule 1.5 g Intravenous
Background Metronidazole Small molecule 250 mg Oral
Background Metronidazole Small molecule 1 g Oral

Indications

No indication recorded.