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

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: University Hospital, Ghent

Current Primary Outcome: Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation. [ Time Frame: 12 months post-surgery ]

A CT scan is performed.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain assessment. [ Time Frame: after 1 year ]
  • Discomfort assessment. [ Time Frame: after 1 year ]
  • Use of oral analgetics. [ Time Frame: after 1 year ]
  • Wound morbidity. [ Time Frame: after 4 weeks ]
  • Recurrence of hernia. [ Time Frame: after 1 year ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Ghent

Dates:
Date Received: June 15, 2012
Date Started: February 2013
Date Completion: December 2015
Last Updated: December 4, 2014
Last Verified: December 2014