MedDataX Logo

Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics

NCT ID: NCT00508690

Last Updated: 2012-09-19

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

584 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-12-31

Brief Summary

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

The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.

Detailed Description

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

The use of antibiotic prophylaxis in patients who undergo elective colorectal surgery is now accepted universally. But the rout of administration should be systematic, oral, or both is controversial. Furthermore, although many trails have been performed, no trial limited to laparoscopic surgery is performed. We compare 2 approaches - oral and systemic versus systemic antibiotic prophylaxis - in limited to elective laparoscopic colorectal surgery.

Conditions

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

Colorectal Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Antibiotic Prophylaxis Colorectal Surgery Laparoscopy

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

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IV

Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

Group Type ACTIVE_COMPARATOR

cefmetazole

Intervention Type DRUG

Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

Oral/IV

2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

Group Type ACTIVE_COMPARATOR

kanamycin/metronidazole

Intervention Type DRUG

2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

Interventions

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

cefmetazole

Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

Intervention Type DRUG

kanamycin/metronidazole

2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

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 tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection

Exclusion Criteria

* ECOG Performance Status \>=2
* Age\<20
* Any organ dysfunction
* Ileus
* Preoperative infectious disease
* Antibiotic administration before surgery
* Steroid administration before surgery
* Neo-adjuvant radiation and/or chemo therapy
* Severe diabetes mellitus
* Pregnancy/lactational woman
* Severe allergy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Japan Multinational Trial Organization

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hiroaki Hata

member

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Hiroaki Hata, MD

Role: PRINCIPAL_INVESTIGATOR

National Hospital Organization Kyoto Medical Center

Locations

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

Kyoto Univercity Hospital

Kyoto, Kyoto, Japan

Site Status

National Hospital Organization, Kyoto Medical Center

Kyoto, Kyoto, Japan

Site Status

Kyoto Katsura Hospital

Kyoto, Kyoto, Japan

Site Status

Tenriyorozu Hospital

Tenri, Nara, Japan

Site Status

Kitano Hospital

Osaka, Osaka, Japan

Site Status

Countries

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

Japan

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 UMIN000000776

Other Identifiers

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

UMIN000000776

Identifier Type: -

Identifier Source: secondary_id

JMTO PREV07-01

Identifier Type: -

Identifier Source: org_study_id