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Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery

NCT03475680 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2022-05-17

No results posted yet for this study

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

Interventions

DRUG

Sennosides colonic preparation

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

DRUG

Oral Gentamycin

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

DRUG

Oral Ornidazole

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

DRUG

Oral placebo Gentamycin

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

DRUG

Oral placebo Ornidazole

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-08
Primary Completion
2021-08-26
Completion
2022-03-23

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03475680 on ClinicalTrials.gov