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The Economic Impact of Four Varieties of Mesh Inguinal Hernia Repair- a Double-Blinded, Prospective, Randomized Trial

This study has been terminated.
(Inadequate accrural rates)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00416364
First Posted: December 28, 2006
Last Update Posted: December 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
United States Naval Medical Center, Portsmouth
  Purpose
There are a variety of methods to repair inguinal hernias. Each has its advocate and may confer advantages to individual patients. Postoperative pain, convalescence, recurrence, and economics have all been evaluated however none in a randomized blinded fashion. Recently, investigators have attempted to address some of these concerns with new prosthetic materials. The preferred method of repair currently employs a tension free technique using mesh prosthesis. The approach as advocated by Lichtenstein involves reinforcing the floor of the inquinal canal with an onlay mesh. Newer approaches use a double layer mesh that reinforces the floor in a preperitoneal and onlay technique (Prolene Hernia System) while obliterating the internal inguinal ring or by the Mesh Plug repair (bioresorbable or permanent) which reinforces the inguinal floor with an onlay mesh while obliterating the internal inguinal ring. Currently no study has compared these techniques for ease of performance, postoperative pain, convalescence, quality of life, or cost in a randomized double blinded fashion. NMCP is uniquely qualified to compare these repairs prospectively and blinded to best assess the most cost effective approach which causes the least pain. A prospective double-blinded randomized trial comparing the Lichtenstein onlay mesh technique to Prolene Hernia Sytem (PHS), Mesh Plug Repair (MPR), or Gore Bioresorbable plug for postoperative pain, duration of convalescence, cost, impact on quality of life and ease of performance is proposed. Impact on quality of life will be assessed serially with the SF 12 which is a validated survey used with serial measures in the acute setting.

Condition
Inguinal Hernia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Economic Impact of Four Varieties of Mesh Inguinal Hernia Repair- a Double-Blinded, Prospective, Randomized Trial

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, Portsmouth:

Primary Outcome Measures:
  • Comparison of Visual Analogue Pain Scale between groups to assess differences in percieved postoperative pain. [ Time Frame: 4 weeks ]

Enrollment: 23
Study Start Date: March 2006
Study Completion Date: October 2007
Groups/Cohorts
1
2
3
4

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
AD males with primary hernia
Criteria

Inclusion Criteria:

  • Unilateral primary inguinal hernia presenting for repair

Exclusion Criteria:

  • Recurrent repairs
  • Females
  • Bilateral repairs
  • Repairs done with other operative procedures
  Contacts and Locations
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): NCT00416364


Locations
United States, Virginia
Naval Medical Center Department of Surgery
Portsmouth, Virginia, United States, 23708
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
Investigators
Principal Investigator: Paul A Lucha, DO Naval Medical Center Department of Surgery- Portsmouth, VA
  More Information

Responsible Party: CAPT Paul Lucha, NMCP
ClinicalTrials.gov Identifier: NCT00416364     History of Changes
Other Study ID Numbers: P06-020
First Submitted: December 27, 2006
First Posted: December 28, 2006
Last Update Posted: December 5, 2007
Last Verified: December 2007

Keywords provided by United States Naval Medical Center, Portsmouth:
hernia
inguinal
quality of life

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal


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