Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery

• Status: Recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone Our hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Gentamicins; Ornidazole; Senna Extract; Sennoside A&B; Sennosides

Criteria

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 colo-proctectomy

• Scheduled abdominoperineal restion 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 colonization with multidrug-resistant enterobacteriacea

• 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