Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• 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 colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

Our Hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

• 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 segmental colectomy for colon cancer

• With Signed consent

• And affiliated to the French social security system

Exclusion Criteria:

• Emergent surgery

• Scheduled total or subtotal colectomy (defined as a colectomy extended from the right colon to a least the left colonic angle)

• Scheduled transverse colectomy

• Scheduled associated proctectomy

• Scheduled associated concomitant resection of another organ (liver, etc.), except the abdominal wall

• Previous segmental colectomy

• Associated inflammatory bowel disease

• Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery)

• 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