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van CCT (UK)

van CCT (UK)

'Validation of the EuraHS-quality of life questionnaire for patients with ventral abdominal wall hernia'

- candidate number22952
- NTR NumberNTR5582
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-okt-2015
- Secondary IDs 2015-76 METC
- Public Title'Validation of the EuraHS-quality of life questionnaire for patients with ventral abdominal wall hernia'
- Scientific Title'Validation of the EuraHS-quality of life questionnaire for patients with ventral abdominal wall hernia'
- hypothesisThe EuraHS-QoL questionnaire is a valid instrument to measure quality-of-life before and after ventral hernia repair.
- Healt Condition(s) or Problem(s) studiedHernia
- Inclusion criteria- Age between 18 and 80 years
- Able to read and understand the Dutch language
- Exclusion criteria- - any patient that is considered unable to provide a reliable answer to the questionnaire (example: severe dementia, mental retardation, language barrier etc).
- - Patients with a life expectancy less than 24 months
- - Patients with chronic steroid dependency
- - Patients with rectus diastasis (without additional ventral hernia)
- - Patients with parastomal hernia(s)
- - Pregnant women
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2016
- planned closingdate1-jan-2018
- Target number of participants170
- Interventionsnone
- Primary outcomePrimary objective: The aim of this study is to evaluate the validity and reliability of a novel ventral hernia quality of life score (EuraHS-QoL) to assess pain, restrictions and cosmetic discomfort of patients with ventral hernias before and after reconstructive surgery.
- Secondary outcomeSecondary objectives: Assessment of the QoL preoperative, 2-4 weeks, and twice at 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, VRS (Verbal Rating Score) for pain at 2-4 weeks and 12 months, pain medication as needed.
- Timepoints- before the operation (RAND-36, EuraHS-QoL) questionnaire
- 2-4 weeks after the surgery (EuraHS-QoL CCS)
- 12 months after surgery (CCS, EuraHS-QoL).and again two weeks later both questionnaires at home.
- Trial web sitenone
- statusplanned
- Sponsor/Initiator Elkerliek ziekenhuis Helmond, Catharina Hospital Eindhoven, Maria Middelares ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
- Publicationsnone
- Brief summary1. SUMMARY
Rationale: Ventral hernias are frequently encountered in the surgical outpatient clinic. Many techniques have been described to repair both incisional and primairy ventral hernias, though very few studies have evaluated the outcome in terms of quality of life following these surgical interventions. In part, this can be attributed to the absence of a proper investigational tool. Several quality of life questionnaires have been validated for ventral hernias, though non of them can be used both pre- and postoperatively and combine both esthetical appearance of the abdomen and function outcome. The EuraHS-QoL questionnaire is a unique tool especially developed to measure quality of life in hernia patients.

Objective: Validation of the EuraHS-QoL by evaluating specificity and statistical validity

Study design: Prospective cohort study with questionnaire inquiries

Methods: All patients will be asked to fill out the RAND-36 (Based on SF-36) quality of life (QoL) questionnaire and the European registry of abdominal wall hernias quality-of-life (EuraHS-QoL) questionnaire preoperative and the EuraHS-QoL and Caroline Comfort Scale (CCS) postoperatively. Once after 2-4 weeks and twice after one year follow-up with an interval of 2 weeks.

Study population: 170 patients with ventral hernia scheduled for surgical repair that will complete the test-retest measurement at one year follow up and 60 healthy volunteers.

Study Duration: the study will end when 170 patient have completed the test-retest measurement after 1 year post-op
- Main changes (audit trail)
- RECORD7-okt-2015 - 4-apr-2016

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