Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hiroaki Hata, Japan Multinational Trial Organization
ClinicalTrials.gov Identifier:
NCT00508690
First received: July 27, 2007
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics

Resource links provided by NLM:

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 ]

Enrollment: 584
Study Start Date: September 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IV
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
Active Comparator: 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
 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

Locations
Japan
Tenriyorozu Hospital
Tenri, Nara, Japan, 6328552
National Hospital Organization, Kyoto Medical Center
Kyoto, Japan, 612-8555
Kyoto Univercity Hospital
Kyoto, Japan, 606-8507
Kyoto Katsura Hospital
Kyoto, Japan, 6158256
Kitano Hospital
Osaka, Japan, 5308480
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: Hiroaki Hata, member, Japan Multinational Trial Organization
ClinicalTrials.gov Identifier: NCT00508690     History of Changes
Other Study ID Numbers: JMTO PREV07-01, UMIN000000776
Study First Received: July 27, 2007
Last Updated: September 18, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Japan Multinational Trial Organization:
Antibiotic Prophylaxis
Colorectal Surgery
Laparoscopy

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Bacterial Agents
Cefmetazole
 Kanamycin
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 21, 2013