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Session: Abstract Session: Quality

ESCP 1 - ESCP Best Paper - Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior to Rectal Surgery (MOBILE2): A Multicentre, Double-Blinded, Randomised Controlled Trial

Monday, June 3, 2024
2:01 PM – 2:07 PM ET, USA
Location: Room 314-317

    Abstract Podium Presenter(s)

  • Laura Koskenvuo, MD, PhD (she/her/hers)

    Consultant
    Helsinki University Hospital
    University of Helsinki, Finland

    All relevant financial disclosures have been managed and will be listed below.
    This individual has no financial relationships with ineligible companies.

Background: Surgical site infections (SSIs) - especially anastomotic dehiscence – are major contributors to complications and mortality after rectal surgery. The role of mechanical and oral antibiotic bowel preparation (MOABP) in preventing complications of rectal surgery is currently disputed.

Methods: In this multicentre, double-blinded placebo-controlled randomised controlled trial, patients undergoing rectal resection with primary anastomosis between March 2020 and October 2022 were randomly assigned to either MOABP (oral regimen: neomycin + metronidazole) or mechanical bowel preparation (MBP) + placebo in three university hospitals in Finland. Patients were stratified according to tumor distance from the anal verge and neoadjuvant treatment given. Key pre-randomisation exclusion criteria were reasons preventing MBP or oral antibiotic use and post-randomisation exclusion criteria were the lack of surgery or colorectal/coloanal anastomosis. The primary outcome was overall cumulative postoperative complications measured using the Comprehensive Complication Index (CCI) and key secondary outcomes were SSIs and anastomotic dehiscences (all within 30 days). The trial is registered with ClinicalTrials.gov, number NCT04281667.

Findings: A total of 610 patients were randomised and 565 patients were included in the modified intention-to-treat analyses (277 for MOABP and 288 for MBP + placebo). Patients assigned to MOABP experienced less overall postoperative complications (media
n CCI 0 (interquartile range (IQR): 0 –8.66) versus 8.66 (IQR: 0 – 20.9), respectively, Wilcoxon effect size 0.146, p = 0.001), less SSIs (23 [8.3%] versus 48 [16.7%] patients, odds ratio 0.453 [95% confidence interval 0.267 – 0.767]), and less anastomotic dehiscences (16 [5.8%] versus 39 [13.5%] patients, odds ratio 0..391 [95% confidence interval 0..213 – 0..718]) compared with patients randomised to MBP + placebo.

Conclusions: MOABP reduced overall postoperative complications as well as rates of SSIs and anastomotic dehiscences in patients undergoing rectal surgery compared with MBP + placebo.