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

• 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

Arm && Interventions

Group	Intervention	Description
TAPP repair	TAPP repair for inguinal hernias	TAPP repair for inguinal hernia
TEP repair	Carolina Comfort Scale	TEP repair for inguinal hernia
TAPP repair	Carolina Comfort Scale	TAPP repair for inguinal hernia
TEP repair	EuraHS-QoL questionnaire	TEP repair for inguinal hernia
TEP repair	TEP repair for inguinal hernia	TEP repair for inguinal hernia
TAPP repair	EuraHS-QoL questionnaire	TAPP repair for inguinal hernia

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)

University Hospital Ghent; 🇧🇪 Ghent, Belgium

AZ Maria Middelares; 🇧🇪 Ghent, Belgium

Heilig Hart Ziekenhuis; 🇧🇪 Mol, Belgium