Rebound Hernia Repair Device Mesh Trial

Minnesota Medical Development, Inc.70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Inguinal Hernia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of Kentucky Dept. Of Surgery

Lexington, Kentucky, United States

The Ohio State Medical Center, Dept. of Surgery

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Presence of hernia recurrence

Time frame: 2 years

Secondary Outcomes

Pain and discomfort to patients using VAS

Time frame: 2 years