Mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation only prior rectal surgery (MOBILE2): a multicentre, double-blinded, randomised controlled trial-study protocol.
INTRODUCTION
Mechanical bowel preparation (MBP) prior to rectal surgery is widely used. Based on retrospective data many guidelines recommend mechanical and oral antibiotic bowel preparation (MOABP) to reduce postoperative complications and specifically surgical site infections (SSIs). The primary aim of this study is to examine whether MOABP reduces complications of rectal surgery.


METHODS AND ANALYSIS
The MOBILE2 (Mechanical Bowel Preparation and Oral Antibiotics vs Mechanical Bowel Preparation Only Prior Rectal Surgery) trial is a multicentre, double-blinded, parallel group, superiority, randomised controlled trial comparing MOABP to MBP among patients scheduled for rectal surgery with colorectal or coloanal anastomosis. The patients randomised to the MOABP group receive 1 g neomycin and 1 g metronidazole two times on a day prior to surgery and patients randomised to the MBP group receive identical placebo. Based on power calculations, 604 patients will be enrolled in the study. The primary outcome is Comprehensive Complication Index within 30 days after surgery. Secondary outcomes are SSIs within 30 days after surgery, the number and classification of anastomosis dehiscences, the length of hospital stay, mortality within 90 days after surgery and the number of patients who received adjuvant treatment if needed. Tertiary outcomes are overall survival, disease-specific survival, recurrence-free survival and difference in quality-of-life before and 1 year after surgery. In addition, the microbiota differences in colon mucosa are analysed.


ETHICS AND DISSEMINATION
The Ethics Committee of Helsinki University Hospital approved the study. The findings will be disseminated in peer-reviewed academic journals.


TRIAL REGISTRATION NUMBER
NCT04281667.
['Koskenvuo|Laura|L|0000-0001-8335-7942', 'Lunkka|Pipsa|P|', 'Varpe|Pirita|P|', 'Hyöty|Marja|M|', 'Satokari|Reetta|R|', 'Haapamäki|Carola|C|', 'Lepistö|Anna|A|', 'Sallinen|Ville|V|']
D000900:Anti-Bacterial Agents D003106:Colon D006801:Humans D015337:Multicenter Studies as Topic D011300:Preoperative Care D016032:Randomized Controlled Trials as Topic D012007:Rectum D012189:Retrospective Studies D013530:Surgical Wound Infection
surgery colorectal surgery gastrointestinal tumours