NCT00636831

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

4.5 years

First QC Date

March 10, 2008

Last Update Submit

February 6, 2012

Conditions

Inguinal Hernia

Keywords

ProphylacticAntibioticInfectionPrimary case

Outcome Measures

Primary Outcomes (1)

  • infectious complication

    two year

Secondary Outcomes (1)

  • Recurrence of inguinal hernia

    two year

Study Arms (2)

cont

PLACEBO COMPARATOR
Drug: Antibiotic: cefazolin Sodium

intervention

ACTIVE COMPARATOR
Drug: Antibiotic: cefazolin Sodium

Interventions

Antibiotic: cefazolin SodiumDRUG

1g continuous IV at 30 minutes before starting operation

contintervention

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nihon University School of Medicine, Department of Surgery

Tokyo, 179-0072, Japan

Location

MeSH Terms

Conditions

Hernia, InguinalInfections

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 17, 2008

Study Start

July 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations

JP(1)