Primary Unilateral Inguinal Hernias
Conditions
Brief summary
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.
Interventions
PROCEDURETAPP repair for inguinal hernias
PROCEDURETEP repair for inguinal hernia
OTHEREuraHS-QoL questionnaire
questionnaire administration
OTHERCarolina Comfort Scale
questionnaire administration
Sponsors
University Hospital, Ghent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assessment of the EuraHS-QoL | 1 year after start study | questionnaire assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in EuraHS-QoL assessment | preoperatively (at inclusion), 3 weeks and 1 year, postoperatively recurrence rate at 12months | clinical evaluation, Carolina Comfort Scale™ questionnaire, EuraHS-QoL questionnaire, Visual Analogue Scale and Verbal Rating Score. |
Countries
Belgium
Outcome results
None listed