Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

February 15, 2006 updated by: National Cancer Center, Japan

Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin

To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Use of prophylactic antibiotics in elective colorectal surgery is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a multicenter randomized trial of single-dose vs. three doses of the second-generation cephalosporin, cefmetazole.

Study Type

Interventional

Enrollment

500

Phase

  • Phase 3

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

      • Kanazawa, Japan
        • Ishikawa Prefectural Central Hospital
      • Kashiwa, Japan
        • National Cancer Center East Hospital
      • Nagoya, Japan
        • Nagoya Medical Center
      • Niigata, Japan
        • Niigata Cancer Center Hospital
      • Osaka, Japan
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
      • Tokyo, Japan
        • National Cancer Center Hospital
      • Yamagata, Japan
        • Yamagata Prefectural Central Hospital

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
  • Elective colorectal resection

Exclusion Criteria:

  • Emergent operation
  • Ileus
  • No resection
  • Preoperative infectious diseases
  • Penicillin or cephalosporin allergy
  • Antibiotics administration before surgery
  • Inflammatory bowel diseases
  • Angina or myocardial infarction
  • Renal dysfunction
  • Diabetes mellitus
  • Steroid administration before surgery

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of incisional surgical site infection (SSI)

Secondary Outcome Measures

Outcome Measure
Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Shin Fujita, MD. PhD., Japan National Cancer Center Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

May 1, 2004

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (Estimate)

February 16, 2006

Study Record Updates

Last Update Posted (Estimate)

February 16, 2006

Last Update Submitted That Met QC Criteria

February 15, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Other Study ID Numbers

  • C000000069

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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