Status:
TERMINATED
Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 o...
Detailed Description
Preoperative mechanical bowel preparation (MBP) has been proposed in an attempt to reduce the colonic fecal load and to limit the risk of surgical site contamination, thus theoretically limiting the r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2022
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT03475680
Start Date
August 8 2018
End Date
March 23 2022
Last Update
May 17 2022
Active Locations (1)
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1
Service de chirurgie Colorectale / Hôpital Beaujon
Clichy, France, 92110