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:
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT00416364
First received: December 27, 2006
Last updated: December 4, 2007
Last verified: December 2007
  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 ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: March 2006
Study Completion Date: October 2007

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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
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: 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

No publications provided

Responsible Party: CAPT Paul Lucha, NMCP
ClinicalTrials.gov Identifier: NCT00416364     History of Changes
Other Study ID Numbers: P06-020
Study First Received: December 27, 2006
Last Updated: December 4, 2007
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on September 16, 2014