Overview

This trial is active, not recruiting.

Condition inguinal hernia
Treatments rebound hrd, standard hernia mesh (vitamesh)
Phase phase 4
Sponsor Minnesota Medical Development, Inc.
Collaborator University of Kentucky
Start date September 2009
End date March 2012
Trial size 70 participants
Trial identifier NCT00968773, Rebound HRD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Competent adults who have a unilateral, bilateral inguinal hernia that is primary in nature.
rebound hrd
Laparoscopic TEP inguinal hernia repair using the Rebound HRD and no fixation
(Active Comparator)
Competent adults who have a unilateral or bilateral inguinal hernia that is primary in nature.
standard hernia mesh (vitamesh) VitaMesh
Laparoscopic TEP inguinal hernia repair using standard hernia mesh with fixation

Primary Outcomes

Measure
Presence of hernia recurrence
time frame: 2 years

Secondary Outcomes

Measure
Pain and discomfort to patients using VAS
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Rebound Hernia Repair Device Trial
Principal investigator John S Roth, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Minnesota Medical Development, Inc..