Rebound Hernia Repair Device Mesh Trial

Inguinal Hernia Clinical Trial

Official title:

Rebound Hernia Repair Device Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00968773
• Other study ID #: Rebound HRD
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 27, 2009
• Last updated: March 14, 2016
• Start date: September 2009
• Est. completion date: September 2013

Study information

• Verified date: September 2009
• Source: Minnesota Medical Development, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Device:
• Rebound HRD
Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation
• Standard hernia mesh (VitaMesh)
Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation

Locations

Country	Name	City	State
United States	The Ohio State Medical Center, Dept. of Surgery	Columbus	Ohio
United States	University of Kentucky Dept. Of Surgery	Lexington	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Minnesota Medical Development, Inc.	Ohio State University, University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of hernia recurrence		2 years	No
Secondary	Pain and discomfort to patients using VAS		2 years	No