Clinical trial · Interventional
Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery
Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (COLONPREP Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of inclusions
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Gentamycin | Drug | — | UNRESOLVED |
| Oral Ornidazole | Drug | — | UNRESOLVED |
| Oral placebo Gentamycin | Drug | — | UNRESOLVED |
| Oral placebo Ornidazole | Drug | — | UNRESOLVED |
| Sennosides colonic preparation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1) " MBP and oral antibiotics " group
- description
- Sennosides colonic preparation Oral Gentamycin Oral Ornidazole * Sennosides colonic preparation (X-PREP) : 1 per day, on day -2 and day -1. * Gentamycin : 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials. * Ornidazole : 1. g per day (2 tablet per day), on day -2 and day -1; In tablets.
- interventionNames
- Drug: Sennosides colonic preparation
- Drug: Oral Gentamycin
- Drug: Oral Ornidazole
- type
- PLACEBO_COMPARATOR
- label
- 2) " MBP alone " group
- description
- Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole * Sennosides colonic preparation (X-PREP) : 1 per day, on day -2 and day -1. * Placebo for oral gentamycin: Same presentation as oral gentamycin x4 per day on day -2 and day -1. - Placebo for oral ornidazole : Same presentation as oral ornidazole 1g per day (2 tablet per day) on day -2 and day -1.
- interventionNames
- Drug: Sennosides colonic preparation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available