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

Unilateral Inguinal Hernia Clinical Trial

— REBOUND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622712
• Other study ID #: 2011/823
• Status: Completed
• Phase: N/A
• Start date: February 1, 2013
• Est. completion date: September 2, 2014

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: September 2, 2014
• Est. primary completion date: September 2, 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Unilateral Inguinal Hernia

Intervention

Device:
• Rebound HRD Mesh
Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.

Locations

Country	Name	City	State
Belgium	ASZ Aalst	Aalst
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Medri

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.	A CT scan is performed.	12 months post-surgery
Secondary	Pain assessment.		after 1 year
Secondary	Discomfort assessment.		after 1 year
Secondary	Use of oral analgetics.		after 1 year
Secondary	Wound morbidity.		after 4 weeks
Secondary	Recurrence of hernia.		after 1 year

External Links

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