Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery
Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin
1 other identifier
interventional
500
1 country
7
Brief Summary
To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2004
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 15, 2006
CompletedFirst Posted
Study publicly available on registry
February 16, 2006
CompletedFebruary 16, 2006
February 1, 2006
February 15, 2006
February 15, 2006
Conditions
Keywords
Outcome Measures
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
Interventions
Eligibility Criteria
You may qualify if:
- Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
- Elective colorectal resection
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Ishikawa Prefectural Central Hospital
Kanazawa, Japan
National Cancer Center East Hospital
Kashiwa, Japan
Nagoya Medical Center
Nagoya, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan
National Cancer Center Hospital
Tokyo, Japan
Yamagata Prefectural Central Hospital
Yamagata, Japan
Related Publications (1)
Fujita S, Saito N, Yamada T, Takii Y, Kondo K, Ohue M, Ikeda E, Moriya Y. Randomized, multicenter trial of antibiotic prophylaxis in elective colorectal surgery: single dose vs 3 doses of a second-generation cephalosporin without metronidazole and oral antibiotics. Arch Surg. 2007 Jul;142(7):657-61. doi: 10.1001/archsurg.142.7.657.
PMID: 17638804DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shin Fujita, MD. PhD.
Japan National Cancer Center Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
February 15, 2006
First Posted
February 16, 2006
Study Start
May 1, 2004
Study Completion
July 1, 2005
Last Updated
February 16, 2006
Record last verified: 2006-02