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A multicenter observational study trial validating Quality of Life assessment using EuraHS Quality of Life score and Carolinas Comfort scaleâ„¢ in patients before and after laparoscopic unilateral inguinal hernia repair.
Depending on the treating physician patients will receive a TAPP or TEP repair for their inguinal hernia and a self-gripping mesh will be used for the repair (Parietex Progrip Mesh).
Primary endpoint will be assessment by the EuraHS-QoL at 1 year after laparoscopic repair of an unilateral inguinal hernia using the Anatomic ProGripâ„¢ Laparoscopic self-fixating mesh.
Secondary endpoints are assessment of the QoL 3 preoperative, 3 weeks and 1 year postoperative, recurrence rate at 12 months, intra-operative and post-operative complications, post-operative hospital stay, operation time and time to place the mesh, VAS (Visual Analog Scale) for pain at several control points, VRS (Verbal Rating Score) for pain at 3 weeks and 12 months, pain medication needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAPP repair | TAPP repair for inguinal hernia |
| |
| TEP repair | TEP repair for inguinal hernia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAPP repair for inguinal hernias | Procedure |
| ||
| TEP repair for inguinal hernia |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of the EuraHS-QoL | questionnaire assessment | 1 year after start study |
| Measure | Description | Time Frame |
|---|---|---|
| change in EuraHS-QoL assessment | clinical evaluation, Carolina Comfort Scaleâ„¢ questionnaire, EuraHS-QoL questionnaire, Visual Analogue Scale and Verbal Rating Score. | preoperatively (at inclusion), 3 weeks and 1 year, postoperatively recurrence rate at 12months |
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Inclusion Criteria:
Exclusion Criteria:
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patients undergoing laparoscopic unilateral inguinal hernia repair
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Maria Middelares | Ghent | 9000 | Belgium | |||
| University Hospital Ghent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27316825 | Derived | Muysoms FE, Vanlander A, Ceulemans R, Kyle-Leinhase I, Michiels M, Jacobs I, Pletinckx P, Berrevoet F. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument. Surgery. 2016 Nov;160(5):1344-1357. doi: 10.1016/j.surg.2016.04.026. Epub 2016 Jun 14. |
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| Procedure |
|
| EuraHS-QoL questionnaire | Other | questionnaire administration |
|
| Carolina Comfort Scale | Other | questionnaire administration |
|
| Ghent |
| 9000 |
| Belgium |
| Heilig Hart Ziekenhuis | Mol | Belgium |