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Prophylactic Antibiotic Use in Hernioplasty (RCT-herniation)

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Antibiotic: cefazolin Sodium
Sponsored by
Nihon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inguinal Hernia focused on measuring Prophylactic, Antibiotic, Infection, Primary case

Eligibility Criteria

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

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

Sites / Locations

  • Nihon University School of Medicine, Department of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

cont

intervention

Arm Description

Outcomes

Primary Outcome Measures

infectious complication

Secondary Outcome Measures

Recurrence of inguinal hernia

Full Information

First Posted
March 10, 2008
Last Updated
February 6, 2012
Sponsor
Nihon University
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1. Study Identification

Unique Protocol Identification Number
NCT00636831
Brief Title
Prophylactic Antibiotic Use in Hernioplasty
Acronym
RCT-herniation
Official Title
Prophylactic Antibiotic Use in Inguinal Hernioplasty: A Placebo-controlled, Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nihon University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Prophylactic, Antibiotic, Infection, Primary case

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cont
Arm Type
Placebo Comparator
Arm Title
intervention
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Antibiotic: cefazolin Sodium
Intervention Description
1g continuous IV at 30 minutes before starting operation
Primary Outcome Measure Information:
Title
infectious complication
Time Frame
two year
Secondary Outcome Measure Information:
Title
Recurrence of inguinal hernia
Time Frame
two year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Nihon University School of Medicine, Department of Surgery
City
Tokyo
ZIP/Postal Code
179-0072
Country
Japan

12. IPD Sharing Statement

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Prophylactic Antibiotic Use in Hernioplasty

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