Prophylactic Antibiotic Use in Hernioplasty | NCT00636831

Studies
Prophylactic Antibiotic Use in Hernioplasty

NCT00636831

Sponsor

Nihon University

Status

Completed

Last Update Posted

Feb 7, 2012Estimated

Enrollment

400Actual

Phase

Phase 3

Conditions

Inguinal Hernia

Interventions

Antibiotic: cefazolin Sodium

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 2012

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

Jul 2007

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Mar 10, 2008

First Submission Date that Met QC Criteria

Mar 10, 2008

First Posted Date

Mar 17, 2008Estimated

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 6, 2012

Last Update Posted Date

Feb 7, 2012Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether prophylactic antibiotic use in inguinal hernioplasty are effective in prevention of infectious complication.

Detailed Description

Not provided

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

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cont	Placebo Comparator		Drug: Antibiotic: cefazolin Sodium
intervention	Active Comparator		Drug: Antibiotic: cefazolin Sodium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antibiotic: cefazolin Sodium	Drug	1g continuous IV at 30 minutes before starting operation	cont intervention

Measure	Description	Time Frame
infectious complication		two year

Measure	Description	Time Frame
Recurrence of inguinal hernia		two year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary inguinal hernia
Elective surgery
Must be older than 20 years of age
Must not have any serious complication

Exclusion Criteria:

Incarceration
Recurrence
Drug allergy
Diabetes mellitus
Malignant diseases
Serious heart diseases
Psychological diseases
Pregnancy
Have been medicated with corticosteroids

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nihon University School of Medicine, Department of Surgery		Tokyo		179-0072	Japan

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal
D007239	Infections

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided