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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508690
• Other study ID #: JMTO PREV07-01
• Secondary ID: UMIN000000776
• Status: Completed
• Phase: Phase 3
• First received: July 27, 2007
• Last updated: September 18, 2012
• Start date: September 2007
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: Japan Multinational Trial Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• cefmetazole
Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
• kanamycin/metronidazole
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

Locations

Country	Name	City	State
Japan	Kyoto Katsura Hospital	Kyoto
Japan	Kyoto Univercity Hospital	Kyoto
Japan	National Hospital Organization, Kyoto Medical Center	Kyoto
Japan	Kitano Hospital	Osaka
Japan	Tenriyorozu Hospital	Tenri	Nara

Sponsors (1)

Lead Sponsor	Collaborator
Japan Multinational Trial Organization

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and classification of surgical site infection (SSI)		Within the first 30 days after surgery	No
Secondary	Incidence of colitis, other infectious diseases and other postoperative complications.		Within the first 30 days after surgery	No

External Links

•   UMIN Clinical Trial Registry: Unique trial number UMIN000000776