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

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
cefmetazole
kanamycin/metronidazole
Sponsored by
Japan Multinational Trial Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Neoplasms focused on measuring Antibiotic Prophylaxis, Colorectal Surgery, Laparoscopy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tenriyorozu Hospital
  • Kyoto Univercity Hospital
  • National Hospital Organization, Kyoto Medical Center
  • Kyoto Katsura Hospital
  • Kitano Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IV

Oral/IV

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence and classification of surgical site infection (SSI)

Secondary Outcome Measures

Incidence of colitis, other infectious diseases and other postoperative complications.

Full Information

First Posted
July 27, 2007
Last Updated
September 18, 2012
Sponsor
Japan Multinational Trial Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00508690
Brief Title
Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
Official Title
Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Japan Multinational Trial Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Antibiotic Prophylaxis, Colorectal Surgery, Laparoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
584 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV
Arm Type
Active Comparator
Arm Description
Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
Arm Title
Oral/IV
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
cefmetazole
Intervention Description
Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
Intervention Type
Drug
Intervention Name(s)
kanamycin/metronidazole
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence and classification of surgical site infection (SSI)
Time Frame
Within the first 30 days after surgery
Secondary Outcome Measure Information:
Title
Incidence of colitis, other infectious diseases and other postoperative complications.
Time Frame
Within the first 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Hata, MD
Organizational Affiliation
National Hospital Organization Kyoto Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tenriyorozu Hospital
City
Tenri
State/Province
Nara
ZIP/Postal Code
6328552
Country
Japan
Facility Name
Kyoto Univercity Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
National Hospital Organization, Kyoto Medical Center
City
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Kyoto Katsura Hospital
City
Kyoto
ZIP/Postal Code
6158256
Country
Japan
Facility Name
Kitano Hospital
City
Osaka
ZIP/Postal Code
5308480
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.umin.ac.jp/ctr/index.htm
Description
UMIN Clinical Trial Registry: Unique trial number UMIN000000776

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

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