Preoperative oral antibiotics with versus without mechanical bowel preparation to reduce surgical site infections following colonic resection: Protocol for an international randomized controlled trial (ORALEV2)

Aim Surgical site infections (SSIs) are common after colonic surgery. SSIs can cause relevant morbidity and increase costs of care. Preoperative oral antibiotics can reduce the incidence of SSIs after resection of the colon, but the role of mechanical bowel preparation (MBP) is debated. This study aims to assess the impact of a combined regimen of oral antibiotics and MBP on SSIs after colonic surgery. Methods An international, multicentre, pragmatic, adaptive, parallel-group, randomized controlled trial will be conducted across Europe. Adult patients scheduled to undergo elective colonic resection will be assessed for inclusion. Patients will be randomized into one of two treatment arms: (1) preoperative oral antibiotics without MBP (control); (2) preoperative oral antibiotics with MBP (experimental). All patients will receive intravenous antibiotics at anaesthetic induction. The primary aim will be 30-day SSI, assessed by a blinded nurse. Additional end-points include safety, morbidity and mortality, satisfaction with the preparation, time to return of bowel function, time to complete recovery and time to discharge, long-term results. Analyses will be performed with a modified intention-to-treat approach. Interim analyses are planned. Discussion This will be the first randomized clinical trial to assess the efficacy and safety of preoperative oral antibiotics plus MBP versus preoperative oral antibiotics only, before colonic surgery. The knowledge obtained could help to establish the ideal preparation for patients scheduled to undergo resection of the colon. Full protocol NCT04161599.