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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Primary Unilateral Inguinal Hernias

Treatments: Procedure: TEP repair for inguinal hernia; Procedure: TAPP repair for inguinal hernias; Other: Carolina Comfort Scale; Other: EuraHS-QoL questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT01936584

EC/2013/381

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

101 participants in 2 patient groups

TAPP repair

Description:

TAPP repair for inguinal hernia

Treatment:

Other: Carolina Comfort Scale

Other: EuraHS-QoL questionnaire

Procedure: TAPP repair for inguinal hernias

TEP repair

Description:

TEP repair for inguinal hernia

Treatment:

Other: Carolina Comfort Scale

Procedure: TEP repair for inguinal hernia

Other: EuraHS-QoL questionnaire