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

Primary Unilateral Inguinal Hernias Clinical Trial

— LIQUOR  

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™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936584
• Other study ID #: EC/2013/381
• Status: Completed
• Phase: N/A
• First received: September 2, 2013
• Last updated: September 17, 2015
• Start date: September 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Primary Unilateral Inguinal Hernias

Intervention

Procedure:
• TAPP repair for inguinal hernias

• TEP repair for inguinal hernia

Other:
• EuraHS-QoL questionnaire
questionnaire administration
• Carolina Comfort Scale
questionnaire administration

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Ghent
Belgium	University Hospital Ghent	Ghent
Belgium	Heilig Hart Ziekenhuis	Mol

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of the EuraHS-QoL	questionnaire assessment	1 year after start study	No
Secondary	change in EuraHS-QoL assessment	clinical evaluation, Carolina Comfort Scale™ questionnaire, EuraHS-QoL questionnaire, Visual Analogue Scale and Verbal Rating Score.	preoperatively (at inclusion), 3 weeks and 1 year, postoperatively recurrence rate at 12months	No