Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery

NCT03491540 | Completed Phase 3

• 1 other identifier: P160938J
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

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

Conditions

Rectal Cancer Surgery

Keywords

Mechanical Bowel Preparation (MBP); Oral antibiotics; Rectal cancer surgery; Surgical site infection

Outcome Measures

Primary Outcomes (1)

• Postoperative 30-day surgical site infection (SSI).

  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.

  30 days

Secondary Outcomes (11)

• Overall postoperative morbidity

  30 days

• Severe postoperative morbidity

  30 days

• Postoperative mortality

  30 days

• Postoperative anastomotic leakage

  90 days

• Postoperative length of hospital stay

  Up to 90 days

Study Arms (2)

1) " MBP and oral antibiotics " group

EXPERIMENTAL

Sennosides colonic preparation Oral Gentamycin Oral Ornidazole

Drug: Sennosides colonic preparation; Drug: Oral Gentamycin; Drug: Oral Ornidazole

2) " MBP alone " group

PLACEBO COMPARATOR

Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole

Drug: Sennosides colonic preparation; Drug: Oral Placebo Gentamycin; Drug: Oral Placebo Ornidazole

Interventions

Sennosides colonic preparation DRUG

Mechanical bowel preparation : Sennosides colonic preparation (X-PREP) 1 per day, on day -2 and day -1

1) " MBP and oral antibiotics " group; 2) " MBP alone " group

Oral Gentamycin DRUG

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

1) " MBP and oral antibiotics " group

Oral Ornidazole DRUG

Oral ornidazole : Ornidazole 1 g per day (2 tablet per day), on day -2 and day -1; In tablets

1) " MBP and oral antibiotics " group

Oral Placebo Gentamycin DRUG

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

2) " MBP alone " group

Oral Placebo Ornidazole DRUG

Placebo for oral ornidazole : Same presentation as oral ornidazole 1g per day (2 tablets per day) on day -2 and day -1

2) " MBP alone " group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de chirurgie viscérale, cancérologique / Hôpital Saint-Louis

Paris, Île-de-France Region, 75010, France

Location

Related Publications (1)

• 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.

  PMID: 36748942 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Gentamicins; Ornidazole

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participants and investigators are unaware of the intervention assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: April 9, 2018
• Study Start: September 3, 2018
• Primary Completion: October 23, 2023
• Study Completion: December 12, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)