Clinical trial NCT01936584: Validation of Quality of Life Assessment After Laparoscopic TAPP and TEP Surgery of Inguinal Hernias Using EuraHS of Life Score and Carolinas Comfort Scale™
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™
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Unilateral Inguinal Hernias
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing laparoscopic unilateral inguinal hernia repair

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.


Eligibility criteria: 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

Primary outcomes:
measure: assessment of the EuraHS-QoL
timeFrame: 1 year after start study
Secondary outcomes:
measure: change in EuraHS-QoL assessment
timeFrame: preoperatively (at inclusion), 3 weeks and 1 year, postoperatively recurrence rate at 12months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Mol
country: Belgium
facility: Heilig Hart Ziekenhuis
Study officials:
References:
citation: 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.