A Randomised Study Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery (REaCT-NSQIP)

OTT 18-03

The REaCT NSQIP will compare oral antibiotics vs. no antibiotics, which are two standards of care treatments for preoperative preparation of the bowel prior to colorectal surgery

2018-10-23

2025-09-01

2026-12-01

Recruiting

Early phase I

432

Inclusion Criteria: * Patients undergoing elective, non-emergency colon, resection surgery or abdominal perineal resection and no other requirements exists for a mechanical bowel preparation (as determined by the operating surgeon) * 18 years of age or older * Able to provide oral consent Exclusion Criteria: * Contraindication to the oral antibiotics, including allergies or adverse reactions to either metronidazole or neomycin * Undergoing a rectal resection with a planned anastomosis (these patients will all receive MBP) * Emergency surgery where no opportunity to administer preoperative oral antibiotics exists * Requirement for a MBP (i.e. rectal resection with pelvic anastomosis, intraoperative colonoscopy, or at the discretion of the treating surgeon

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 432, 'type': 'ESTIMATED'}}

2024-04-03