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

Sponsor:	Japan Multinational Trial Organization
Information provided by:	Japan Multinational Trial Organization
ClinicalTrials.gov Identifier:	NCT00508690

Purpose

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

Condition	Intervention	Phase
Colorectal Neoplasms	Drug: cefmetazole Drug: kanamycin/metronidazole	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Cancer Colorectal Cancer Surgery

Drug Information available for: Kanamycin Kanamycin sulfate Cefmetazole Cefmetazole sodium Metronidazole hydrochloride Metronidazole phosphate Metronidazole

U.S. FDA Resources

Further study details as provided by Japan Multinational Trial Organization:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	580
Study Start Date:	September 2007
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
IV: Active Comparator Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery	Drug: cefmetazole Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
Oral/IV: 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	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

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508690

Contacts

Contact: Hiroaki Hata, MD

81756419161

hhata-kyt@umin.ac.jp

Locations

Japan
National Hospital Organization, Kyoto Medical Center	Recruiting
Kyoto, Japan, 612-8555
Contact: Hiroaki Hata, MD 81-756419161 hhata-kyt@umin.ac.jp
Principal Investigator: Hiroaki Hata, MD
Sub-Investigator: Takashi Yamaguchi, MD
Kyoto Univercity Hospital	Recruiting
Kyoto, Japan, 606-8507
Contact: Yoshiharu Sakai, MD, PHD 81757513650 ysakai@kuhp.kyoto-u.ac.jp
Principal Investigator: Yoshiharu Sakai, MD, PHD
Sub-Investigator: Akinari Nomura, MD

Sponsors and Collaborators

Japan Multinational Trial Organization

Investigators

Principal Investigator:

Hiroaki Hata, MD

National Hospital Organization, Kyoto Medical Center

More Information

Additional Information:

UMIN Clinical Trial Registry: Unique trial number UMIN000000776 This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Japan Multinational Trial Organization ( Hiroaki Hata )
Study ID Numbers:	JMTO PREV07-01, UMIN000000776
Study First Received:	July 27, 2007
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00508690 History of Changes
Health Authority:	Japan: Institutional Review Board

Keywords provided by Japan Multinational Trial Organization:

Antibiotic Prophylaxis
Colorectal Surgery
Laparoscopy

Additional relevant MeSH terms:

Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Kanamycin
Rectal Diseases
Anti-Bacterial Agents
Antiparasitic Agents
Neoplasms by Site
Therapeutic Uses

Digestive System Neoplasms
Enzyme Inhibitors
Intestinal Diseases
Intestinal Neoplasms
Pharmacologic Actions
Cefmetazole
Protein Synthesis Inhibitors
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009