Preparation with Mechanical Bowel Cleansing or/and Oral Antibiotics or Nothing for Elective Colorectal Surgery: Two-Two-Arm Multicentre Randomised Controlled Studies (MECCLANT –C and –R Trials)

Abstract

Background: Mechanical bowel preparation (MBP) for elective colorectal surgery has mostly been abandoned the last two decades. More recent evidence from US databases show that MBP combined with oral antibiotics (OA) reduces surgical site infections (SSI) after elective colorectal surgery. Hypothesis‐∗∗Aim: Administration of OA, and not MBP, is the main factor that prevents SSI. Rectal cancer surgery differs from colon cancer surgery in that the former is associated with defunctioning stoma, which requires an empty colon. Patients‐methods: Patients to undergo elective colectomy for cancer or diverticular disease are randomized to two arms; Arm A: no MBP; Arm B: MBP combined with OA (MECCLAND‐C Trial). Patients scheduled for elective low anterior rectal resection for cancer are randomized to two arms; Arm A: MBP only; Arm B: MBP combined with OA (MECCLAND‐R Trial). Participating centers are advised to implement enhanced recovery programmes in all patients. Primary end‐points: Thirty‐day SSI rate which includes (1) superficial wound infection, (2) deep wound infection, and (3) intra‐abdominal infection. Statistical points: Considering a SSI rate of 0.12 for Arm A vs a SSI rate of 0.06 for Arm B, a randomization rate of 1:1 and negligible drop‐off rate, the sample size of either Arm of either Trial should be 356 patients.