Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery

NCT ID: NCT03491540

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 414 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2023-12-12

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.

Conditions

Rectal Cancer Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1) " MBP and oral antibiotics " group

Sennosides colonic preparation Oral Gentamycin Oral Ornidazole

Group Type: EXPERIMENTAL

Sennosides colonic preparation

Intervention Type: DRUG

Mechanical bowel preparation :

Sennosides colonic preparation (X-PREP)

1 per day, on day -2 and day -1

Oral Gentamycin

Intervention Type: DRUG

Oral gentamycin:

Gentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials

Oral Ornidazole

Intervention Type: DRUG

Oral ornidazole :

Ornidazole

1 g per day (2 tablet per day), on day -2 and day -1; In tablets

2) " MBP alone " group

Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole

Group Type: PLACEBO_COMPARATOR

Sennosides colonic preparation

Intervention Type: DRUG

Mechanical bowel preparation :

Sennosides colonic preparation (X-PREP)

1 per day, on day -2 and day -1

Oral Placebo Gentamycin

Intervention Type: DRUG

Placebo for oral gentamycin :

Same presentation as oral gentamycin x4 per day on day -2 and day -1

Oral Placebo Ornidazole

Intervention Type: DRUG

Placebo for oral ornidazole :

Same presentation as oral ornidazole

1g per day (2 tablets per day) on day -2 and day -1

Interventions

Sennosides colonic preparation

Mechanical bowel preparation :

Sennosides colonic preparation (X-PREP)

1 per day, on day -2 and day -1

Intervention Type: DRUG

Oral Gentamycin

Oral gentamycin:

Gentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials

Intervention Type: DRUG

Oral Ornidazole

Oral ornidazole :

Ornidazole

1 g per day (2 tablet per day), on day -2 and day -1; In tablets

Intervention Type: DRUG

Oral Placebo Gentamycin

Placebo for oral gentamycin :

Same presentation as oral gentamycin x4 per day on day -2 and day -1

Intervention Type: DRUG

Oral Placebo Ornidazole

Placebo for oral ornidazole :

Same presentation as oral ornidazole

1g per day (2 tablets per day) on day -2 and day -1

Intervention Type: DRUG

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de chirurgie viscérale, cancérologique / Hôpital Saint-Louis

Paris, Île-de-France Region, France

Countries

France

References

Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.

Reference Type: DERIVED

PMID: 36748942 (View on PubMed)

Other Identifiers

P160938J

Identifier Type: -

Identifier Source: org_study_id