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

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

Study Type: Interventional

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

Study Primary Completion Date: May 2010

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.

Intervention(s) in this Clinical Trial

• Drug: cefmetazole
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: IV
  • 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

Primary Measures

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

Secondary Measures

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

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Japan Multinational Trial Organization

Overall Clinical Trial Officials and Contacts

Hiroaki Hata, MD Principal Investigator National Hospital Organization, Kyoto Medical Center  

Overall Contact: Hiroaki Hata, MD 81756419161 hhata-kyt@umin.ac.jp

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00508690

Study ID Number: JMTO PREV07-01

ClinicalTrials.gov Identifier: NCT00508690

Health Authority: Japan: Institutional Review Board

UMIN Clinical Trial Registry: Unique trial number UMIN000000776