Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics

UMIN ID: UMIN000000776

Registered date:01/08/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colorectal tumor with planned elective laparoscopic resection
• Date of first enrollment: 2007/11/01
• Target sample size: 580
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Incidence and classification of surgical site infection (SSI)
• Secondary Outcome: Incidence of colitis, other infectious diseases and other postoperative complications.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) ECOG Performance Status >=2 2) Age<20 3) Any organ dysfunction 4) Ileus 5) Preoperative infectious disease 6) Antibiotic administration before surgery 7) Steroid administration before surgery 8) Neo-adjuvant radiation and/or chemo therapy 9) Diabetes mellitus 10) Pregnancy/lactational woman 11) Severe allergy

Related Information

• Primary Sponsor: The Japan-Multinational Trial Organization(JMTO)
• Source(s) of Monetary Support: None
• Secondary ID(s): NCT00508690