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

NCT00416364 | Terminated

• 1 other identifier: P06-020
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inguinal Hernia

Keywords

hernia; inguinal; quality of life

Outcome Measures

Primary Outcomes (1)

• Comparison of Visual Analogue Pain Scale between groups to assess differences in percieved postoperative pain.

  4 weeks

Study Arms (4)

1

2

3

4

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

AD males with primary hernia

You may qualify if:

• Unilateral primary inguinal hernia presenting for repair

You may not qualify if:

• Recurrent repairs
• Females
• Bilateral repairs
• Repairs done with other operative procedures

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Department of Surgery

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal; Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul A Lucha, DO

  Naval Medical Center Department of Surgery- Portsmouth, VA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: March 1, 2006
• Study Completion: October 1, 2007
• Last Updated: December 5, 2007

Record last verified: 2007-12

Locations

US (1)