MOBILE2.

Study name	Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery (MOBILE2)
Methods	Study type: interventional (Clinical Trial) Study design Allocation: randomised Intervention Model: parallel assignment Masking: quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Participants	Condition or disease: Rectal Adenocarcinoma, Rectum Neoplasm, Rectum Carcinoma, Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Surgical Site Infection, Surgery‐‐Complications Inclusion criteria Patients scheduled for anterior rectal resection with primary anastomosis Exclusion Criteria Emergency operation Bowel obstruction Existing stoma Other reason preventing mechanical bowel preparation Allergy to neomycin or metronidazole Age < 18 years Lack of co‐operation Exclusion criteria Patient did not undergo surgery Anterior resection was not performed Colonic anastomosis was not performed Target sample size: 604
Interventions	Treatment arms MOABP group: bowel preparation using MBP and oral antibiotics MBP group: Bowel preparation using MBP and placebo. Mechanical bowel preparation The patients drink 2 L of PEG and 1 L of clear fluids of the patient’s choice. The MBP can be started 2 days before the surgery at 15:00 and must be completed by 15:00 on a day prior to the surgery. Oral antibiotic prophylaxis The patients take 1 g of neomycin or placebo orally at 15:00 and 23:00 and 1 g of metronidazole or placebo orally at 15:00 and 23:00. Perioperative intravenous antibiotic prophylaxis Cefuroxime 1.5 g and metronidazole 500 mg approximately 1 hour before surgery. The intravenous antibiotics are repeated if surgery is still ongoing 3 hours after the first intravenous dose.
Outcomes	Primary outcome Comprehensive Complication Index (CCI) within 30 days after surgery Secondary outcomes SSI within 30 days after surgery (according to the Centers for Disease and Control and Prevention criteria),including superficial incisional infection, deep incisional infection and organ/space infection The number and classification of anastomosis dehiscence within 30 days of procedure The length of hospital stay Mortality within 90 days after surgery (any cause) The number of patients who received adjuvant treatment divided by the number of patients that needed it within 6 months of the procedure. Tertiary outcomes (long‐term follow‐up) 5‐year overall survival 5‐year disease‐specific survival 5‐year recurrence‐free survival Difference in quality‐of‐life
Starting date	Date of registration: February 24, 2020 Actual Study Start Date: March 18, 2020 Estimated Primary Completion Date: March 2022 Recruitment Status: Recruiting (Last Update Posted: June 3, 2021)
Contact information	Contact person: Laura Koskenvuo Affiliation: Helsinki University Hospital Country of origin: Finland
Notes	Ethics approval: The research plan has been evaluated by the Finnish National Committee on Medical Research Ethics (TUKIJA) and Finnish Medicines Agency (FIMEA) has been notified. The EUDRA CT number for the clinical drug trials has been applied (No 2018‐004355‐20). The research plan was further approved by the local ethics committee of Helsinki University Hospital and in each participating centres’ institutional review board (Helsinki University Hospital, Tampere University Hospital and Turku University Hospital) Source of funding: Cancer Society of Finland