Primary Unilateral Inguinal Hernias Clinical Trial
Official title:
Validation of Quality of Life Assessment After Laparoscopic TAPP and TEP Surgery of Inguinal Hernias Using EuraHS of Life Score and Carolinas Comfort Scale™
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective