drugset / Trial / NCT04281667

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery

NCT04281667 ↗

Phase 4 Active not recruiting 604 enrolled Helsinki University Central Hospital
RandomizedParallel-groupQuadruple-blindPrevention

Summary

MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.

Timeline

Start
2020-03-18
Primary completion
2022-11-09
Completion
2027-10-10

Outcome

Met primary endpoint

paper Patients in the MOABP group experienced fewer overall postoperative complications (median [IQR] Comprehensive Complication Index, 0 [0-8.66] vs 8.66 [0-20.92]; Wilcoxon effect size, 0.146; P < .001) PMID 38506889 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Metronidazole Small molecule 1 g Oral
Subject Neomycin Unknown 1 g Oral
Background polyethylene glycol Other / unclassified 2000 ml —