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

Phase 3

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: kanamycin/metronidazole; Drug: cefmetazole

• Registration Number: NCT00508690
• Lead Sponsor: Japan Multinational Trial Organization

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 Timeline

• Study First Submitted: 2007-07-27
• Study First Submitted QC: 2007-07-27
• Study First Posted: 2007-07-30
• Study Start: 2007-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-18
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 584

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral/IV	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
IV	cefmetazole	Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

Primary Outcome Measures

Name	Time	Method
Incidence and classification of surgical site infection (SSI)	Within the first 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of colitis, other infectious diseases and other postoperative complications.	Within the first 30 days after surgery

Trial Locations

Locations (5)

Tenriyorozu Hospital; 🇯🇵 Tenri, Nara, Japan

National Hospital Organization, Kyoto Medical Center; 🇯🇵 Kyoto, Japan

Kyoto Katsura Hospital; 🇯🇵 Kyoto, Japan

Kitano Hospital; 🇯🇵 Osaka, Japan

Kyoto Univercity Hospital; 🇯🇵 Kyoto, Japan