Validation of Quality of Life Assessment After Laparoscopic TAPP and TEP Surgery of Inguinal Hernias Using EuraHS of Life Score and Carolinas Comfort Scale™
NCT ID: NCT01936584
Last Updated: 2015-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
101 participants
OBSERVATIONAL
2013-09-30
2015-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TAPP repair
TAPP repair for inguinal hernia
TAPP repair for inguinal hernias
EuraHS-QoL questionnaire
questionnaire administration
Carolina Comfort Scale
questionnaire administration
TEP repair
TEP repair for inguinal hernia
TEP repair for inguinal hernia
EuraHS-QoL questionnaire
questionnaire administration
Carolina Comfort Scale
questionnaire administration
Interventions
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TAPP repair for inguinal hernias
TEP repair for inguinal hernia
EuraHS-QoL questionnaire
questionnaire administration
Carolina Comfort Scale
questionnaire administration
Eligibility Criteria
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Inclusion Criteria
* Primary unilateral inguinal hernia undergoing a preperitoneal laparoscopic repair.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Locations
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AZ Maria Middelares
Ghent, , Belgium
University Hospital Ghent
Ghent, , Belgium
Heilig Hart Ziekenhuis
Mol, , Belgium
Countries
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References
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Muysoms FE, Vanlander A, Ceulemans R, Kyle-Leinhase I, Michiels M, Jacobs I, Pletinckx P, Berrevoet F. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument. Surgery. 2016 Nov;160(5):1344-1357. doi: 10.1016/j.surg.2016.04.026. Epub 2016 Jun 14.
Other Identifiers
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EC/2013/381
Identifier Type: -
Identifier Source: org_study_id
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