Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics - Tabular View

Tracking Information

First Received Date ^ICMJE

July 27, 2007

Last Updated Date

August 3, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence and classification of surgical site infection (SSI) [ Time Frame: Within the first 30 days after surgery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Incidence and classification of surgical site infection (SSI) [ Time Frame: Within the first 30 days after surgery ]

Change History

Complete list of historical versions of study NCT00508690 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of colitis, other infectious diseases and other postoperative complications. [ Time Frame: Within the first 30 days after surgery ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Incidence of colitis, other infectious diseases and other postoperative complications. [ Time Frame: Within the first 30 days after surgery ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Colorectal Neoplasms

Intervention ^ICMJE

Drug: cefmetazole
Drug: kanamycin/metronidazole

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

580

Estimated Completion Date

May 2012

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Hiroaki Hata, MD

81756419161

hhata-kyt@umin.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00508690

Responsible Party

Hiroaki Hata, Japan Multinational Trial Organization

Study ID Numbers ^ICMJE

JMTO PREV07-01, UMIN000000776

Study Sponsor ^ICMJE

Japan Multinational Trial Organization

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Hiroaki Hata, MD

National Hospital Organization, Kyoto Medical Center

Information Provided By

Japan Multinational Trial Organization

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP