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Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (PREPACOL2 Study)
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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Service de chirurgie viscérale, cancérologique / Hôpital Saint-Louis
Paris, Île-de-France Region, France
Start Date
September 3, 2018
Primary Completion Date
October 23, 2023
Completion Date
December 12, 2023
Last Updated
January 5, 2024
414
ACTUAL participants
Sennosides colonic preparation
DRUG
Oral Gentamycin
DRUG
Oral Ornidazole
DRUG
Oral Placebo Gentamycin
DRUG
Oral Placebo Ornidazole
DRUG
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06982664