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Prophylactic Antibiotic Use in Hernioplasty (RCT-herniation)

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ClinicalTrials.gov Identifier: NCT00636831
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : February 7, 2012
Sponsor:
Information provided by (Responsible Party):
Takero Mazaki, MD, PhD, Nihon University

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

Condition or disease Intervention/treatment Phase
Inguinal Hernia Drug: Antibiotic: cefazolin Sodium Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Antibiotic Use in Inguinal Hernioplasty: A Placebo-controlled, Double-blind Trial
Study Start Date : July 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Hernia

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




Primary Outcome Measures :
  1. infectious complication [ Time Frame: two year ]

Secondary Outcome Measures :
  1. Recurrence of inguinal hernia [ Time Frame: two year ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636831


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

Responsible Party: Takero Mazaki, MD, PhD, Dr, Nihon University
ClinicalTrials.gov Identifier: NCT00636831     History of Changes
Other Study ID Numbers: Hikari-0701
First Posted: March 17, 2008    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Takero Mazaki, MD, PhD, Nihon University:
Prophylactic
Antibiotic
Infection
Primary case

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