Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
2 other identifiers
interventional
584
1 country
5
Brief Summary
The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2007
Typical duration for phase_3
5 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
First Submitted
Initial submission to the registry
July 27, 2007
CompletedFirst Posted
Study publicly available on registry
July 30, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedSeptember 19, 2012
September 1, 2012
4.3 years
July 27, 2007
September 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and classification of surgical site infection (SSI)
Within the first 30 days after surgery
Secondary Outcomes (1)
Incidence of colitis, other infectious diseases and other postoperative complications.
Within the first 30 days after surgery
Study Arms (2)
IV
ACTIVE COMPARATORIntravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
Oral/IV
ACTIVE COMPARATOR2 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Kyoto Univercity Hospital
Kyoto, Kyoto, 606-8507, Japan
National Hospital Organization, Kyoto Medical Center
Kyoto, Kyoto, 612-8555, Japan
Kyoto Katsura Hospital
Kyoto, Kyoto, 6158256, Japan
Tenriyorozu Hospital
Tenri, Nara, 6328552, Japan
Kitano Hospital
Osaka, Osaka, 5308480, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hiroaki Hata, MD
National Hospital Organization Kyoto Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- member
Study Record Dates
First Submitted
July 27, 2007
First Posted
July 30, 2007
Study Start
September 1, 2007
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
September 19, 2012
Record last verified: 2012-09