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

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ClinicalTrials.gov Identifier: NCT00508690
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : September 19, 2012
Sponsor:
Information provided by (Responsible Party):
Hiroaki Hata, Japan Multinational Trial Organization

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

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: cefmetazole Drug: kanamycin/metronidazole Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
Study Start Date : September 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508690


Locations
Japan
Tenriyorozu Hospital
Tenri, Nara, Japan, 6328552
Kyoto Univercity Hospital
Kyoto, Japan, 606-8507
National Hospital Organization, Kyoto Medical Center
Kyoto, Japan, 612-8555
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

Additional Information:
Responsible Party: Hiroaki Hata, member, Japan Multinational Trial Organization
ClinicalTrials.gov Identifier: NCT00508690     History of Changes
Other Study ID Numbers: JMTO PREV07-01
UMIN000000776
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Bacterial Agents
Kanamycin
Cefmetazole
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action