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

1. 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

The EuraHS-QoL questionnaire is a valid instrument to measure quality-of-life before and after ventral hernia repair.

- 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.

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