Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
Information source: Japan Multinational Trial Organization
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Neoplasms
Intervention: cefmetazole (Drug); kanamycin/metronidazole (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Japan Multinational Trial Organization Official(s) and/or principal investigator(s):
Hiroaki Hata, MD, Principal Investigator, Affiliation: National Hospital Organization, Kyoto Medical Center
Overall contact:
Hiroaki Hata, MD, Phone: 81756419161, Email: hhata-kyt@umin.ac.jp
Summary
The purpose of this study is to determine optimal prophylactic antibiotics administration
method in elective laparoscopic colorectal surgery.
Clinical Details
Official title: Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Incidence and classification of surgical site infection (SSI)
Secondary outcome: Incidence of colitis, other infectious diseases and other postoperative complications.
Detailed 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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hiroaki Hata, MD, Phone: 81756419161, Email: hhata-kyt@umin.ac.jp
National Hospital Organization, Kyoto Medical Center, Kyoto 612-8555, Japan; Recruiting
Hiroaki Hata, MD, Phone: 81-756419161, Email: hhata-kyt@umin.ac.jp
Hiroaki Hata, MD, Principal Investigator
Takashi Yamaguchi, MD, Sub-Investigator
Kyoto Univercity Hospital, Kyoto 606-8507, Japan; Recruiting
Yoshiharu Sakai, MD, PHD, Phone: 81757513650, Email: ysakai@kuhp.kyoto-u.ac.jp
Yoshiharu Sakai, MD, PHD, Principal Investigator
Akinari Nomura, MD, Sub-Investigator
Additional Information
UMIN Clinical Trial Registry: Unique trial number UMIN000000776
Starting date: September 2007
Ending date: May 2010
Last updated: May 6, 2008
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