Skip to main content
OpenTrials
Completed

NCT Number: NCT00292708

Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Surgery Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ishikawa Prefectural Central Hospital, Kanazawa, Japan

Loading trial locations.

About this study

Use of prophylactic antibiotics in elective colorectal surgery is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a multicenter randomized trial of single-dose vs. three doses of the second-generation cephalosporin, cefmetazole.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
  • Elective colorectal resection

Exclusion criteria

  • Emergent operation
  • Ileus
  • No resection
  • Preoperative infectious diseases
  • Penicillin or cephalosporin allergy
  • Antibiotics administration before surgery
  • Inflammatory bowel diseases
  • Angina or myocardial infarction
  • Renal dysfunction
  • Diabetes mellitus
  • Steroid administration before surgery

Treatment and study plan

Cefmetazole (drug)

Drug

Primary outcomes

  1. Incidence of incisional surgical site infection (SSI)

Secondary outcomes

  1. Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay

Sponsors and collaborators

Lead sponsor

National Cancer Center, Japan

Other Gov

Registry information

Official study title

Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin

Important dates

Study start
2004
Study completion
2005
First posted
Feb 16, 2006
Registry last updated
Feb 16, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.