Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery

Phase 3

Completed

• Conditions: Rectal Cancer Surgery
• Interventions: Drug: Sennosides colonic preparation; Drug: Oral Gentamycin; Drug: Oral Placebo Gentamycin; Drug: Oral Ornidazole; Drug: Oral Placebo Ornidazole

• Registration Number: NCT03491540
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-09
• Study Start: 2018-09-03
• Primary Completion: 2023-10-23
• Study Completion: 2023-12-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2) " MBP alone " group	Sennosides colonic preparation	Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
1) " MBP and oral antibiotics " group	Oral Ornidazole	Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
1) " MBP and oral antibiotics " group	Oral Gentamycin	Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
1) " MBP and oral antibiotics " group	Sennosides colonic preparation	Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
2) " MBP alone " group	Oral Placebo Gentamycin	Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
2) " MBP alone " group	Oral Placebo Ornidazole	Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole

Primary Outcome Measures

Name	Time	Method
Postoperative 30-day surgical site infection (SSI).	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 Outcome Measures

Name	Time	Method
Date of adjuvant chemotherapy beginning	90 days	If indicated
Postoperative mortality	30 days	Including all deaths occurring within 30 days after surgery.
Postoperative length of hospital stay	Up to 90 days	Calculated from the day of surgery to the day of hospital discharge.
Rate of multi-resistant bacteria carriage	The day before or the day of surgery	Defined as rate of multi-resistant bacteria carriage
Overall postoperative morbidity	30 days	Including all postoperative complications occurring within 30 days after surgery, defined and classified according to the Clavien-Dindo classification.
Unplanned hospitalization	90 days	Defined as any unplanned hospitalization between surgery and postoperative day 90.
Tolerance of the colonic preparation	The day before surgery	Evaluated using a dedicated questionnaire performed the evening before surgery.
Temporary stoma closure rate	90 days	Define as temporary stoma closure
Severe postoperative morbidity	30 days	Including all complications graded 3 or more according to the Clavien-Dindo classification, and occurring within 30 days after surgery.
Postoperative anastomotic leakage	90 days	Defined as the passing of any intra-colonic content (air, liquid, intestinal content, or radiological contrast) through an anastomosis or by an peri-anastomotic abscess, even in the absence of intra-colonic content leak through the anastomosis, observed in drainages, surgical incision, vagina, during a surgical procedure or on a radiological examination, occurring within 90 days after surgery.
Clostridium difficile colitis occurrence	30 days	Defined as clinical symptoms of clostridium difficile colitis with at least 1 stool sample positive for Clostridium difficile toxin A/B as detected by enzyme-linked immunosorbent assay within 30 days after surgery.

Trial Locations

Locations (1)

Service de chirurgie viscérale, cancérologique / Hôpital Saint-Louis; 🇫🇷 Paris, Ile De France, France