Prophylactic Antibiotic Use in Hernioplasty (RCT-herniation)

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

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


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT00636831

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 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:
Primary case

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents processed this record on April 16, 2014