Rebound Hernia Repair Device Mesh Trial

Phase 4

• Conditions: Inguinal Hernia

• Registration Number: NCT00968773
• Lead Sponsor: Minnesota Medical Development, Inc.

Brief Summary

This is a post-market study of the Rebound Hernia Repair Device to further establish the safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population. The Rebound Hernia Repair Device will be used for its approved indication in comparison to "standard" hernia mesh. Two-way students t-tests, Chi squared analysis and ANOVA will be used to detect differences in variables. The study is sufficiently powered to detect a 25% difference.

The study data will include quality of life assessments, visual analogue scale , SF-36, Carolinas Comfort Scale), recurrence of hernia (technical failure), use of medications (pain) and complications/adverse events.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Status Verified: 2009-09
• Study Start: 2009-09
• Primary Completion: 2012-03
• Study Completion: 2013-09
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 18 to 80 years of age
• Unilateral or bilateral inguinal hernia (moderate in size), primary in nature

Exclusion Criteria

• Unable to provide informed consent
• Assessed as ASA 3 or 4
• Renal failure;creatinine greater than 2.0mg percent
• Ascites as determined by clinical suspicion/ultrasound confirmation
• Known pregnancy
• Femoral hernias
• Diabetes requiring injectable insulin
• Prior lower abdominal surgery through lower midline or Pfannenstiel incision
• TAPP approach
• Requiring anticoagulants during surgery
• Participation in another study involving another device or drug
• Emergent procedures for hernia incarceration and strangulation
• Recurrent inguinal hernias

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Presence of hernia recurrence	2 years

Secondary Outcome Measures

Name	Time	Method
Pain and discomfort to patients using VAS	2 years

Trial Locations

Locations (2)

University of Kentucky Dept. Of Surgery; 🇺🇸 Lexington, Kentucky, United States

The Ohio State Medical Center, Dept. of Surgery; 🇺🇸 Columbus, Ohio, United States