Validation of Quality of Life Assessment After Laparoscopic TAPP and TEP Surgery of Inguinal Hernias Using EuraHS of Life Score and Carolinas Comfort Scale™

Study Overview
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Brief Summary
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A multicenter observational study trial validating Quality of Life assessment using EuraHS Quality of Life score and Carolinas Comfort scale™ 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 ProGrip™ 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.

Official Title
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Validation of Quality of Life Assessment After Laparoscopic TAPP and TEP Surgery of Inguinal Hernias Using EuraHS of Life Score and Carolinas Comfort Scale™

Conditions
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Primary Unilateral Inguinal Hernias

Intervention / Treatment
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* Procedure: TAPP repair for inguinal hernias
* Procedure: TEP repair for inguinal hernia
* Other: EuraHS-QoL questionnaire
* Other: Carolina Comfort Scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent from the patient or his/her legal representative Primary unilateral inguinal hernia undergoing a preperitoneal laparoscopic repair. Exclusion Criteria: No written informed consent Recurrent groin hernia Open hernia repair Bilateral hernias Concomitant repair of another abdominal hernia eg umbilical hernia Hernia repair combined with another surgical procedure Emergency operations, like incarcerated hernias Patients under the age of 18 years and over 80 years Pregnant women ASA score 4 or more Patients unable to perform the QoL assessment, because of language barrier or intellectual incapacity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAPP repair<br>TAPP repair for inguinal hernia | Procedure: TAPP repair for inguinal hernias<br> <br> Other: EuraHS-QoL questionnaire<br>* questionnaire administration<br>Other: Carolina Comfort Scale<br>* questionnaire administration<br>|
| TEP repair<br>TEP repair for inguinal hernia | Procedure: TEP repair for inguinal hernia<br> <br> Other: EuraHS-QoL questionnaire<br>* questionnaire administration<br>Other: Carolina Comfort Scale<br>* questionnaire administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of the EuraHS-QoL | questionnaire assessment | 1 year after start study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in EuraHS-QoL assessment | clinical evaluation, Carolina Comfort Scale™ questionnaire, EuraHS-QoL questionnaire, Visual Analogue Scale and Verbal Rating Score. | preoperatively (at inclusion), 3 weeks and 1 year, postoperatively recurrence rate at 12months |