DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics

Information source: Japan Multinational Trial Organization
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Neoplasms

Intervention: cefmetazole (Drug); kanamycin/metronidazole (Drug)

Phase: Phase 3

Status: Completed

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

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

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

Kyoto Katsura Hospital, Kyoto 6158256, Japan

Kyoto Univercity Hospital, Kyoto 606-8507, Japan

National Hospital Organization, Kyoto Medical Center, Kyoto 612-8555, Japan

Kitano Hospital, Osaka 5308480, Japan

Tenriyorozu Hospital, Tenri, Nara 6328552, Japan

Additional Information

UMIN Clinical Trial Registry: Unique trial number UMIN000000776

Starting date: September 2007
Last updated: September 18, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017