Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery

Last updated: January 3, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

3

Condition

Rectal Cancer

Digestive System Neoplasms

Colon Cancer

Treatment

Oral Ornidazole

Oral Placebo Gentamycin

Oral Placebo Ornidazole

Clinical Study ID

NCT03491540
P160938J
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 18 or more
  • Scheduled to undergo elective restorative laparoscopic cancer of the rectal (<15 cmfrom the anal margin) with sphincter preservation
  • With Signed consent
  • And affiliated to the French social security system

Exclusion

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 anyof 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

Study Design

Total Participants: 414
Treatment Group(s): 5
Primary Treatment: Oral Ornidazole
Phase: 3
Study Start date:
September 03, 2018
Estimated Completion Date:
December 12, 2023

Study 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.

Connect with a study center

  • Service de chirurgie Colorectale / Hôpital Beaujon

    Clichy, Ile De France 92110
    France

    Site Not Available

  • Service de chirurgie viscérale, cancérologique / Hôpital Saint-Louis

    Paris, Ile De France 75010
    France

    Site Not Available

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