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Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery

NCT03491540 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2024-01-05

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 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

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

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 tablets 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
2018-09-03
Primary Completion
2023-10-23
Completion
2023-12-12

Countries

  • France

Study Locations

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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 NCT03491540 on ClinicalTrials.gov