NCT03491540.

Study name	Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery (PREPACOL2)
Methods	Study type: ‐ Study design: Allocation: randomised Intervention model: parallel assignment Masking: double (participant, investigator) Both participants and investigators are unaware of the intervention assignmentPrimary Purpose: prevention
Participants	Condition or disease: rectal cancer surgery Inclusion criteria Patients aged 18 or more Scheduled to undergo elective restorative laparoscopic cancer of the rectal (<15 cm from the anal margin) with sphincter preservation With Signed consent And affiliated to the French social security system Exclusion criteria Emergent surgery Scheduled total coloproctectomy Scheduled abdominoperineal resection with definitive colostomy Scheduled associated concomitant resection of another organ (liver, etc.) Active bacterial infection at the time of surgery or recent antibiotic therapy (up to 15 days before surgery) Associated inflammatory bowel disease Patients with known colonisation with multidrug‐resistant enterobacteriaceae History of allergy or contraindication to the Ornidazole, Gentamycin, X‐PREP or to any of the excipients of the drugs used. Cirrhosis of grade B and C (Child‐Pugh classification) Myasthenia Allergy to one of the other treatments administered for the purpose of the trial (including betadine) Patient suffering from severe central neurologic diseases, fixed or progressive. Pregnant patients Refusal to participate or inability to provide informed consent Target sample size: 400
Interventions	Treatment arms Experimental: "MBP and oral antibiotics "group Placebo Comparator: 2 "MBP alone " group Mechanical bowel preparation Sennosides colonic preparation (X‐PREP); 1 per day, on day ‐2 and day ‐1 Oral antibiotics Gentamycin 80 mg, 4 per day, on day ‐2 and day ‐1; Liquid forms in individual vials Ornidazole 1 g per day (2 tablets per day), on day ‐2 and day ‐1; In tablets
Outcomes	Primary outcome Postoperative 30‐day surgical site infection (SSI) Secondary outcomes Overall postoperative morbidity Severe postoperative morbidity Postoperative mortality Postoperative anastomotic leakage Postoperative length of hospital stay Unplanned hospitalisation Tolerance of the colonic preparation Clostridium difficile colitis occurrence Rate of multiresistant bacteria carriage Date of adjuvant chemotherapy beginning Temporary stoma closure rate
Starting date	Date of registration: April 9, 2018 ActualStudy Start Date: September 3, 2018 Estimated Primary Completion Date: May 31, 2023 Recruitment Status: Recruiting
Contact information	Contact person: Yves Panis and Massimo Giacca Affiliation: Service de chirurgie Colorectale/Hôpital Beaujon Country of origin: France
Notes	Ethics approval: ‐ Source of funding: Assistance Publique ‐ Hôpitaux de Paris