Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (PREPACOL2 Study)
Overview
- Phase
- Phase 3
- Intervention
- Sennosides colonic preparation
- Conditions
- Rectal Cancer Surgery
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 414
- Locations
- 1
- Primary Endpoint
- Postoperative 30-day surgical site infection (SSI).
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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
Detailed Description
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. This study's 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 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 risk of postoperative surgical site infection (SSI). However, the benefit of such MBP before colorectal surgery is related to type of procedure performed. Indeed, several randomized controlled trials (RCT) and meta-analyses have demonstrated the absence of benefit of MBP before colon cancer surgery, whereas a recent RCT suggested that MBP before rectal cancer surgery was associated to a significant reduction of postoperative SSI, as compare to the absence of preoperative MBP. Recent studies suggested that the adjunction of oral antibiotics during MBP could help efficiently reduce the risk of postoperative SSI. Indeed, a recent meta-analysis of RCT have suggested that patients preoperatively receiving both MBP and oral antibiotics were exposed to a significantly reduced risk of postoperative SSI, as compared to patients receiving only preoperative MBP. This result was confirmed in a recent RCT which compared preoperative MBP and oral antibiotics versus MBP alone in a heterogeneous population of patients who underwent laparoscopic colonic or rectal surgery. However, to date, no RCT compared the outcomes of an MBP with oral antibiotics to MBP without oral antibiotics in a homogeneous cohort of patients undergoing rectal cancer surgery. 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.
Investigators
Eligibility 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
Arms & Interventions
1) " MBP and oral antibiotics " group
Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
Intervention: Sennosides colonic preparation
1) " MBP and oral antibiotics " group
Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
Intervention: Oral Gentamycin
1) " MBP and oral antibiotics " group
Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
Intervention: Oral Ornidazole
2) " MBP alone " group
Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
Intervention: Sennosides colonic preparation
2) " MBP alone " group
Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
Intervention: Oral Placebo Gentamycin
2) " MBP alone " group
Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
Intervention: Oral Placebo Ornidazole
Outcomes
Primary Outcomes
Postoperative 30-day surgical site infection (SSI).
Time Frame: 30 days
SSI will be defined and classified as superficial, deep and/or organ-space infection on the basis of validated and well-defined criteria developed by the Centers for Disease Control and Prevention (CDC), validated in French by the Comité technique des infections nosocomiales et des infections liées aux soins.
Secondary Outcomes
- Date of adjuvant chemotherapy beginning(90 days)
- Postoperative mortality(30 days)
- Postoperative length of hospital stay(Up to 90 days)
- Tolerance of the colonic preparation(The day before surgery)
- Temporary stoma closure rate(90 days)
- Rate of multi-resistant bacteria carriage(The day before or the day of surgery)
- Overall postoperative morbidity(30 days)
- Unplanned hospitalization(90 days)
- Severe postoperative morbidity(30 days)
- Postoperative anastomotic leakage(90 days)
- Clostridium difficile colitis occurrence(30 days)