Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device (REBOUND)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Medri
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01622712
First received: June 15, 2012
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial.

Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a CT scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.


Condition Intervention
Unilateral Inguinal Hernia
Device: Rebound HRD Mesh

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation. [ Time Frame: 12 months post-surgery ] [ Designated as safety issue: No ]
    A CT scan is performed.


Secondary Outcome Measures:
  • Pain assessment. [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
  • Discomfort assessment. [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
  • Use of oral analgetics. [ Time Frame: after 1 year ] [ Designated as safety issue: No ]
  • Wound morbidity. [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • Recurrence of hernia. [ Time Frame: after 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Unilateral inguinal hernia
A Nitinol containing large pore polypropylene mesh will be placed in patients with unilateral inguinal hernia.
Device: Rebound HRD Mesh
Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective repair for a primary unilateral inguinal hernia OR
  • elective repair for a recurrent unilateral inguinal hernia after non-mesh repair

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622712

Contacts
Contact: Frederik Berrevoet, MD, PhD +32(0)93324892 Frederik.Berrevoet@ugent.be

Locations
Belgium
ASZ Aalst Recruiting
Aalst, Belgium, 9300
Contact: Tijl Vierendeels, MD         
Principal Investigator: Tijl Vierendeels, MD         
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Frederik Berrevoet, MD, PhD    +32(0)93324892    Frederik.Berrevoet@ugent.be   
Principal Investigator: Frederik Berrevoet, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Medri
Investigators
Principal Investigator: Frederik Berrevoet, MD, PhD Ghent University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01622712     History of Changes
Other Study ID Numbers: 2011/823
Study First Received: June 15, 2012
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
inguinal hernia

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on August 20, 2014