Prophylactic Antibiotic Use in Hernioplasty (RCT-herniation)

February 6, 2012 updated by: Takero Mazaki, MD, PhD, Nihon University

Prophylactic Antibiotic Use in Inguinal Hernioplasty: A Placebo-controlled, Double-blind Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 179-0072
        • Nihon University School of Medicine, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: cont
Drug: Antibiotic: cefazolin Sodium
1g continuous IV at 30 minutes before starting operation
Active Comparator: intervention
Drug: Antibiotic: cefazolin Sodium
1g continuous IV at 30 minutes before starting operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
infectious complication
Time Frame: two year
two year

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence of inguinal hernia
Time Frame: two year
two year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nihon University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 10, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 17, 2008

Study Record Updates

Last Update Posted (Estimate)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 6, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hikari-0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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