ORALEV2.

Study name	Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial. (ORALEV2)
Methods	Study type: Interventional Study design Allocation: randomised Intervention model: parallel assignment Masking: single (Outcomes Assessor) Primary purpose: prevention
Participants	Condition or disease: Wounds and Injuries, Surgery‐‐Complications Inclusion criteria Patients of both genders, aged 18 years or above, with colonic disease without contraindications to surgical treatment, diagnosed with neoplasia or diverticular disease (diverticulosis with indication to elective surgery: stricture, chronic constipation), for whom a segmental or total colectomy is indicated. Patients who voluntarily accept to join the study and sign a dedicated written consent. Patients with capability of understanding the study and taking the medications prescribed. Exclusion criteria Patients undergoing urgent surgery (within < 24 hours) Patients who refuse to participate Patients with rectal disease or neoplasia Patients with pre‐existing intra‐abdominal sepsis (abscess, acute diverticulitis) Patients who received preoperative antibiotic treatment for any other reasons during the 2 weeks before surgery Patients with Crohn's disease or ulcerative colitis Patients unlikely to adhere to the treatment prescribed Patients with allergy or contraindication to the medications used in the study Patients who need mechanical bowel preparation Patients with contraindication to the bowel preparation used in the study (Citrafleet®) Patients with kidney failure needing haemodialysis or with hypermagnesaemia Patients with severe heart failurePatients with gastric or duodenal ulcer Patients with mechanical obstruction Patients with toxic megacolon Patients with ascites or rhabdomyolysis Target sample size: 968
Interventions	Treatment arms Group A (experimental): The day before surgery, patients will receive oral ciprofloxacin (750 mg/12 hours, meaning two doses at 12:00 PM and 0:00 PM) and oral metronidazole (250 mg/8 h, meaning three doses at 08:00 AM, 4:00 PM and 0:00 PM) and oral sodium picosulfate (sodium picosulfate/light magnesium oxide/anhydrous citric acid 10 mg/3.5 g/10.97 g per dose, two doses the day before surgery, Citrafleet®) (one sachet at 4:00 PM and one sachet at 7:00 PM). At anaesthetic induction, patients will receive iv cefuroxime 1.5 g and IV metronidazole 1 g. Group B (control): the day before surgery, patients will receive oral ciprofloxacin (750 mg/12 hours, meaning two doses at 12:00 PM and 0:00 PM) and oral metronidazole (250 mg/8 h, meaning three doses at 08:00 AM, 4:00 PM and 0:00 PM). At anaesthetic induction, patients will receive iv cefuroxime 1.5 g andIV metronidazole 1 g.
Outcomes	Primary outcome SSIs (defined as the sum of superficial, deep and organ‐space infections) occurring in each group within 30 days after surgery Secondary outcomes Postoperative ileus Anastomotic leak Kidney failure Complete postoperative recover Length of hospital stay Reintervention Readmission Patient satisfaction Perioperative MBP‐associated hypovolaemia
Starting date	Date of registration: November 13, 2019 EstimatedStudy Start date: September 14, 2021 Estimated Primary Completion Date: May 2023 Recruitment Status: Not yet recruiting (Last Update Posted: August 31, 2021)
Contact information	Contact person: Eloy Espín‐Basany Affiliation: Colorectal Surgery Unit, Hospital Vall d’Hebron, Country of origin: Spain
Notes	Ethics approval: The study has been approved by the Ethics Committee of the Coordinating Centre and by the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) Source of funding: This study is funded by the Instituto de Salud Carlos III of the Spanish Ministry of Science and Innovation through grant PI20/00622