Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery

NCT03475680 | Terminated Phase 3

• 1 other identifier: P161202J
• Study Type: interventional
• Target: 193
• 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 colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation. Our Hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

Conditions

Colon Cancer

Keywords

Mechanical Bowel Preparation (MBP); Oral antibiotics; Colon 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 (10)

• Overall postoperative morbidity

  30 days

• Severe postoperative morbidity

  30 days

• Postoperative mortality

  30 days

• Postoperative anastomotic leakage

  90 days

• Postoperative length of hospital stay

  Day of hospital discharge

Study Arms (4)

1) " MBP and oral antibiotics " group

EXPERIMENTAL

Sennosides colonic preparation Oral Gentamycin Oral Ornidazole * Sennosides colonic preparation (X-PREP) : 1 per day, on day -2 and day -1. * Gentamycin : 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials. * Ornidazole : 1. g per day (2 tablet per day), on day -2 and day -1; In tablets.

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 * Sennosides colonic preparation (X-PREP) : 1 per day, on day -2 and day -1. * Placebo for oral gentamycin: Same presentation as oral gentamycin x4 per day on day -2 and day -1. - Placebo for oral ornidazole : Same presentation as oral ornidazole 1g per day (2 tablet per day) on day -2 and day -1.

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

3) " Oral antibiotics alone " group

EXPERIMENTAL

Oral Gentamycin Oral Ornidazole * Gentamycin : 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials. * Ornidazole : 1. g per day (2 tablet per day), on day -2 and day -1; In tablets.

Drug: Oral Gentamycin; Drug: Oral Ornidazole

4) " No preparation " group

PLACEBO COMPARATOR

Oral placebo Gentamycin Oral placebo Ornidazole \- Placebo for oral gentamycin : Same presentation as oral gentamycin x4 per day on day -2 and day -1 \- Placebo for oral ornidazole : Same presentation as oral ornidazole 1g per day (2 tablet per day) on day -2 and day -1

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

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

1) " MBP and oral antibiotics " group; 3) " Oral antibiotics alone " 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; 3) " Oral antibiotics alone " 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; 4) " No preparation " group

Oral placebo Ornidazole DRUG

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

2) " MBP alone " group; 4) " No preparation " 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 segmental colectomy for colon cancer
• With Signed consent
• And affiliated to the French social security system

You may not qualify if:

• Emergent surgery
• Scheduled total or subtotal colectomy (defined as a colectomy extended from the right colon to a least the left colonic angle)
• Scheduled transverse colectomy
• Scheduled associated proctectomy
• Scheduled associated concomitant resection of another organ (liver, etc.), except the abdominal wall
• Previous segmental colectomy
• Associated inflammatory bowel disease
• Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de chirurgie Colorectale / Hôpital Beaujon

Clichy, 92110, France

Location

MeSH Terms

Conditions

Colonic Neoplasms; Surgical Wound Infection

Interventions

Gentamicins; Ornidazole

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; 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: Double Blind : 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: March 23, 2018
• Study Start: August 8, 2018
• Primary Completion: August 26, 2021
• Study Completion: March 23, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)