Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery (PREPACOL2)

  • STATUS
    Recruiting
  • End date
    Aug 31, 2023
  • participants needed
    400
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 27 May 2022

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

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.

Details
Condition Rectal Cancer Surgery
Treatment Sennosides colonic preparation, Oral Gentamycin, Oral Ornidazole, Oral placebo Gentamycin, Oral placebo Ornidazole
Clinical Study IdentifierNCT03491540
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

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
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