Rebound Hernia Repair Device Mesh Trial

Minnesota Medical Development

Status and phase: Unknown; Phase 4

Conditions: Inguinal Hernia

Treatments: Device: Standard hernia mesh (VitaMesh); Device: Rebound HRD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00968773

Rebound HRD

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

The Rebound hernia repair device with no fixation

Experimental group

Description:

Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature.

Treatment:

Device: Rebound HRD

Standard Hernia Mesh using fixation

Active Comparator group

Description:

Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature.

Treatment:

Device: Standard hernia mesh (VitaMesh)