Clinical trial · Interventional
Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery
Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (PREPACOL2 Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
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 |
|---|---|---|---|
| Rectal Cancer Surgery | — | UNRESOLVED | — |
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 (2)
- type
- EXPERIMENTAL
- label
- 1) " MBP and oral antibiotics " group
- description
- Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
- 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
- interventionNames
- Drug: Sennosides colonic preparation
- Drug: Oral Placebo Gentamycin
- Drug: Oral Placebo Ornidazole
Primary outcomes (1)
- measure
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 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
References
Publications (1)
- DERIVEDWillis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2. PMID 36748942