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)

September 17, 2015 updated by: University Hospital, Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent
      • Ghent, Belgium, 9000
        • AZ Maria Middelares
      • Mol, Belgium
        • Heilig Hart Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing laparoscopic unilateral inguinal hernia repair

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TAPP repair
TAPP repair for inguinal hernia
Procedure: TAPP repair for inguinal hernias
Other: EuraHS-QoL questionnaire
questionnaire administration
Other: Carolina Comfort Scale
questionnaire administration
TEP repair
TEP repair for inguinal hernia
Other: EuraHS-QoL questionnaire
questionnaire administration
Other: Carolina Comfort Scale
questionnaire administration
Procedure: TEP repair for inguinal hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of the EuraHS-QoL
Time Frame: 1 year after start study
questionnaire assessment
1 year after start study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in EuraHS-QoL assessment
Time Frame: 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.
preoperatively (at inclusion), 3 weeks and 1 year, postoperatively recurrence rate at 12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 2, 2013

First Posted (Estimate)

September 6, 2013

Study Record Updates

Last Update Posted (Estimate)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2013/381

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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