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

Japan Multinational Trial Organization

Status and phase: Completed; Phase 3

Conditions: Colorectal Neoplasms

Treatments: Drug: cefmetazole; Drug: kanamycin/metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00508690

JMTO PREV07-01

UMIN000000776

Details and patient eligibility

About

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

Full 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.

Enrollment: 584 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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584 participants in 2 patient groups

IV

Active Comparator group

Description:

Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery

Treatment:

Drug: cefmetazole

Oral/IV

Active Comparator group

Description:

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

Treatment:

Drug: kanamycin/metronidazole