MECCLANT –C and –R Trials.

Study name	Preparation with Mechanical Bowel Cleansing or/and Oral Antibiotics or Nothing for Elective Colorectal Surgery: Two‐Two‐Arm Multicentre Randomised Controlled Studies (MECCLANT –C and –R Trials)
Methods	Study type: interventional Study design Two phase III prospective, randomised, two‐arm, comparative, multicentre studies
Participants	Condition or disease MECCLAND ‐C Trial: patients to undergo surgery for colon cancer, patients to undergo surgery for colonic benign polyps (solitary, multiple), patients to undergo surgery for diverticular disease MECCLAND –R Trial: patients to undergo surgery for rectal cancer with or without protective stoma, patients to undergo surgery for rectal benign polyps (solitary, multiple) Inclusion criteria Scheduled colorectal surgery Exclusion criteria Patients younger than 18 Years of age or older than 85 years of age Patients With preoperative hospital stay >2 days Patients to undergo non‐elective (emergency) operation Patients with contraindication for mechanical bowel preparation Patients physically unstable requiring intensive preoperative resuscitation sepsis, septic shock, Systemic Inflammatory Response Syndrome (SIRS), acute respiratory failure requiring mechanical ventilation, acute renal failure American Society of Anesthesiologists (ASA) Physical Status Classification of 4 or 5 Patients With infection at the site of abdominal incision Patients with a history of Colo‐ectal surgery Patients to undergo defunctioning Ssoma only Patients incapable to communicate and provide informed consent Patients undergoing surgery for IBD Patients undergoing panproctocolectomy for Familial Adenomatous Polyposis (FAP) Target sample size: 356
Interventions	Treatment arms Arm A: no bowel preparation (NBP) Arm B: mechanical bowel preparation plus oral antibiotics (MBP +OA) Mechanical bowel preparation MECCLAND –C trial: Consume per os 3‐4 L of either Klean Prep (Norgine Ltd, Uxbridge, UK) or Fortrans (Beaufour IPSEN Industry, Dreux, France) as MBP. MBP starts at 14:00 and ends by 18:00 on the day prior to surgery. MECCLAND –R trial: Patients of both Arms consume per os 3‐4 L of either Klean Prep (Norgine Ltd, Uxbridge, UK) or Fortrans (Beaufour IPSEN Industry, Dreux, France) as MBP. MBP starts at 14:00 and ends by 18:00 on the day prior to surgery. Oral antibiotic prophylaxis 2 g of neomycin at 19:00 the day prior to surgery and 1.5 g of metronidazole at 21:00 the day prior to surgery. Perioperative intravenous antibiotic prophylaxis 1.5 g cefuroxime and 1g metronidazole one hour prior to first abdominal incision
Outcomes	Primary outcome Surgical site infection (SSI), including superficLal wound infection, deep wound infection, and intraabdominal infection (contaminated fluLd or pus collection) Secondary outcomes Anastomotic leakage 30‐day mortality 30‐day morbidity Paralytic ileus Length of hospital stay Readmission rate
Starting date	Date of registration: ‐ Study Start Date: ‐ Estimated Primary Completion Date: ‐ Recruitment Status: Open/recruiting
Contact information	Contact person: Nikolaos Gouvas Affiliation: Acute Hospitals, Worcester, UK Country of origin: Greece
Notes	Ethics approval: ‐ Source of funding: ‐