Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Ghent (Other)
Overall Status
Unknown status
CT.gov ID
NCT01622712
Collaborator
Medri (Other)
50
Enrollment
2
Locations
1
Arm
33.9
Duration (Months)
25
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Rebound HRD Mesh
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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.
Study Start Date :
Feb 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation. [12 months post-surgery]

    A CT scan is performed.

Secondary Outcome Measures

  1. Pain assessment. [after 1 year]

  2. Discomfort assessment. [after 1 year]

  3. Use of oral analgetics. [after 1 year]

  4. Wound morbidity. [after 4 weeks]

  5. Recurrence of hernia. [after 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 ASZ Aalst Aalst Belgium 9300
2 Ghent University Hospital Ghent Belgium 9000

Sponsors and Collaborators

  • University Hospital, Ghent
  • Medri

Investigators

  • Principal Investigator: Frederik Berrevoet, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01622712
Other Study ID Numbers:
  • 2011/823
First Posted:
Jun 19, 2012
Last Update Posted:
Dec 5, 2014
Last Verified:
Dec 1, 2014
Keywords provided by University Hospital, Ghent
inguinal hernia
Additional relevant MeSH terms:
Hernia
Hernia, Inguinal

Study Results

No Results Posted as of Dec 5, 2014