Trial of Antibiotic Prophylaxis in Elective Colorectal Su... | NCT00292708

Studies
Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

NCT00292708

Sponsor

National Cancer Center, Japan

Status

Completed

Last Update Posted

Feb 16, 2006Estimated

Enrollment

500

Phase

Phase 3

Conditions

Colorectal Surgery

Interventions

Cefmetazole (drug)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Jul 2005

First Submitted Date

Feb 15, 2006

First Submission Date that Met QC Criteria

Feb 15, 2006

First Posted Date

Feb 16, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2006

Last Update Posted Date

Feb 16, 2006Estimated

Description Module

Brief Summary

To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery

Detailed Description

Use of prophylactic antibiotics in elective colorectal surgery is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a multicenter randomized trial of single-dose vs. three doses of the second-generation cephalosporin, cefmetazole.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500

Name	Type	Description	Arm Group Labels	Other Names
Cefmetazole (drug)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of incisional surgical site infection (SSI)

Secondary Outcomes

Measure	Description	Time Frame
Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
Elective colorectal resection

Exclusion Criteria:

Emergent operation
Ileus
No resection
Preoperative infectious diseases
Penicillin or cephalosporin allergy
Antibiotics administration before surgery
Inflammatory bowel diseases
Angina or myocardial infarction
Renal dysfunction
Diabetes mellitus
Steroid administration before surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shin Fujita, MD. PhD.	Japan National Cancer Center Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ishikawa Prefectural Central Hospital		Kanazawa			Japan
National Cancer Center East Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17638804	Derived	Fujita S, Saito N, Yamada T, Takii Y, Kondo K, Ohue M, Ikeda E, Moriya Y. Randomized, multicenter trial of antibiotic prophylaxis in elective colorectal surgery: single dose vs 3 doses of a second-generation cephalosporin without metronidazole and oral antibiotics. Arch Surg. 2007 Jul;142(7):657-61. doi: 10.1001/archsurg.142.7.657.

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

ID	Term
D015311	Cefmetazole
D004364	Pharmaceutical Preparations

ID	Term
D002513	Cephamycins
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577