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

Completed

• Conditions: Primary Unilateral Inguinal Hernias

• Registration Number: NCT01936584
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-17
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assessment of the EuraHS-QoL	1 year after start study	questionnaire assessment

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

AZ Maria Middelares; 🇧🇪 Ghent, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium

Heilig Hart Ziekenhuis; 🇧🇪 Mol, Belgium