Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.

March 4, 2019 updated by: Rybakov Evgeny, MD, State Scientific Centre of Coloproctology, Russian Federation

Randomized Controlled Trial of Antibiotic Prophylaxis in Rectal Cancer Surgery: Oral With Intravenous Versus Intravenous Antibiotics.

This is a randomized, controlled, parallel study to determine the efficiency of oral antibiotics in reduction of surgical site infection (SSI) in rectal cancer surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing rectal cancer surgery in a single centre will assigned randomly to combined preoperative oral antibiotics (metronidazole and erythromycin) and perioperative intravenous antibiotics (cefmetazole) (oral+intravenous group) or to perioperative intravenous antibiotics (cefmetazole) alone (intravenous group). The primary endpoint is the overall rate of SSI.

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 123423
        • Recruiting
        • State Scientific Centre of Coloproctology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a planned of resection of rectum
  • Have signed approved informed consent form for the study.

Exclusion Criteria:

  • Significant simultaneous surgical procedure (e.g., liver resection of metastasis)
  • Bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery
  • Preoperative severe impairment in renal function (creatinine clearance (MDRD) < 30 ml/min)
  • Allergy on the study drugs .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oral with Intravenous
Oral metronidazole and erythromycine administration on the day before surgery with intravenous cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Drug: Oral antibiotic
Metronidazole - 500 mg and Erythromycin - 500 mg per os *3 times at 5 p.m.; 8 p.m., 11 p.m. in a day before surgery
Other Names:
  • Erythromycin
  • Metronidazole
Drug: Intravenous antibiotic
Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
Other Names:
  • Cefoperazone
Drug: Mechanical Bowel Preparation
Beginning of MBP at 4 p.m. in a day before surgery
Other Names:
  • polyethylene glycol
ACTIVE_COMPARATOR: Intravenous
Intravenous dose cefoperazone before surgery (30-90 min) and additional doses every third hour during surgery
Drug: Intravenous antibiotic
Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
Other Names:
  • Cefoperazone
Drug: Mechanical Bowel Preparation
Beginning of MBP at 4 p.m. in a day before surgery
Other Names:
  • polyethylene glycol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Surgical Site Infection
Time Frame: 0 to 30 days
0 to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State Scientific Centre of Coloproctology, Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2017

Primary Completion (ANTICIPATED)

July 31, 2020

Study Completion (ANTICIPATED)

August 31, 2020

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 10, 2018

First Posted (ACTUAL)

February 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 76

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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