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.
Study Type
OBSERVATIONAL
Enrollment
101
questionnaire administration
questionnaire administration
AZ Maria Middelares
Ghent, Belgium
University Hospital Ghent
Ghent, Belgium
Heilig Hart Ziekenhuis
Mol, Belgium
assessment of the EuraHS-QoL
questionnaire assessment
Time frame: 1 year after start study
change in EuraHS-QoL assessment
clinical evaluation, Carolina Comfort Scale™ questionnaire, EuraHS-QoL questionnaire, Visual Analogue Scale and Verbal Rating Score.
Time frame: preoperatively (at inclusion), 3 weeks and 1 year, postoperatively recurrence rate at 12months
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