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

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ClinicalTrials.gov Identifier: NCT01622712
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : June 19, 2012
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
Medri
Information provided by (Responsible Party):
University Hospital, Ghent

Study Description
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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
Unilateral Inguinal Hernia Device: Rebound HRD Mesh Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : February 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia Memory
U.S. FDA Resources

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation. [ Time Frame: 12 months post-surgery ]
    A CT scan is performed.


Secondary Outcome Measures :
  1. Pain assessment. [ Time Frame: after 1 year ]
  2. Discomfort assessment. [ Time Frame: after 1 year ]
  3. Use of oral analgetics. [ Time Frame: after 1 year ]
  4. Wound morbidity. [ Time Frame: after 4 weeks ]
  5. Recurrence of hernia. [ Time Frame: after 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University Hospital, Ghent
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01622712     History of Changes
Other Study ID Numbers: 2011/823
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
inguinal hernia

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