Prophylactic Antibiotic Use in Hernioplasty (RCT-herniation)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takero Mazaki, MD, PhD, Nihon Univerity
ClinicalTrials.gov Identifier:
NCT00636831
First received: March 10, 2008
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Inguinal Hernia
Drug: Antibiotic: cefazolin Sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Antibiotic Use in Inguinal Hernioplasty: A Placebo-controlled, Double-blind Trial

Resource links provided by NLM:


Further study details as provided by Nihon University:

Primary Outcome Measures:
  • infectious complication [ Time Frame: two year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence of inguinal hernia [ Time Frame: two year ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: July 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636831

Locations
Japan
Nihon University School of Medicine, Department of Surgery
Tokyo, Japan, 179-0072
Sponsors and Collaborators
Nihon University
  More Information

No publications provided

Responsible Party: Takero Mazaki, MD, PhD, Dr, Nihon Univerity
ClinicalTrials.gov Identifier: NCT00636831     History of Changes
Other Study ID Numbers: Hikari-0701
Study First Received: March 10, 2008
Last Updated: February 6, 2012
Health Authority: Japan: Nihon University School of Medicine Herima-Hikarigaoka Hospital

Keywords provided by Nihon University:
Prophylactic
Antibiotic
Infection
Primary case

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anti-Bacterial Agents
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 21, 2014