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OpenTrials
Completed

NCT Number: 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™

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.

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Key information

Conditions

Primary Unilateral Inguinal Hernias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Maria Middelares, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAPP repair for inguinal hernias

Procedure

TEP repair for inguinal hernia

Procedure

EuraHS-QoL questionnaire

Other

questionnaire administration

Carolina Comfort Scale

Other

questionnaire administration

Primary outcomes

  1. assessment of the EuraHS-QoL

    Time frame: 1 year after start study

    questionnaire assessment

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: LIQUOR

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 6, 2013
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.