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Completed

NCT Number: NCT01622712

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

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.

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Key information

Conditions

Unilateral Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

ASZ Aalst, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rebound HRD Mesh

Device

Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Medri

Registry information

Official study title

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

Acronym: REBOUND

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2012
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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