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™

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Unilateral Inguinal Hernias

Interventions

Type	Name	Description
PROCEDURE	TAPP repair for inguinal hernias
PROCEDURE	TEP repair for inguinal hernia
OTHER	EuraHS-QoL questionnaire	questionnaire administration
OTHER	Carolina Comfort Scale	questionnaire administration

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-09-06
• Last updated: 2015-09-18

Locations

3 sites across 1 country: Belgium