Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

NCT ID: NCT00292708

Last Updated: 2006-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cefmetazole (drug)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Center, Japan

OTHER_GOV

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shin Fujita, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Japan National Cancer Center Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ishikawa Prefectural Central Hospital

Kanazawa, , Japan

Site Status

National Cancer Center East Hospital

Kashiwa, , Japan

Site Status

Nagoya Medical Center

Nagoya, , Japan

Site Status

Niigata Cancer Center Hospital

Niigata, , Japan

Site Status

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, , Japan

Site Status

National Cancer Center Hospital

Tokyo, , Japan

Site Status

Yamagata Prefectural Central Hospital

Yamagata, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

Fujita S, Saito N, Yamada T, Takii Y, Kondo K, Ohue M, Ikeda E, Moriya Y. Randomized, multicenter trial of antibiotic prophylaxis in elective colorectal surgery: single dose vs 3 doses of a second-generation cephalosporin without metronidazole and oral antibiotics. Arch Surg. 2007 Jul;142(7):657-61. doi: 10.1001/archsurg.142.7.657.

Reference Type DERIVED
PMID: 17638804 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.umin.ac.jp/ctr/index.htm

UMIN Clinical Trial Registry: Unique trial number C000000069

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C000000069

Identifier Type: -

Identifier Source: org_study_id