Effectiveness of total extraperitoneal hernia correction for clinically occult inguinal hernia: a multicenter randomized controlled trial
Not yet recruiting
- Conditions
- Inguinal hernia, clinically occult, TEP, pain, quality of life, cost-effectivenessLiesbreuk, klinisch occult, pijn, kwaliteit van leven, kosteneffectiviteit
- Registration Number
- NL-OMON21825
- Lead Sponsor
- Hospital: Diakonessenhuis Utrecht/ Zeist, the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
Age 18 years or older
- Unilateral groin pain (minimum NRS score of 1 during rest and/or physical activity)
Exclusion Criteria
- Previous inguinal hernia on the symptomatic side
- Previous surgery in inguinal region of the symptomatic side
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in pain intensity, measured in rest and during physical activity by the numeric rating scale (NRS)
- Secondary Outcome Measures
Name Time Method - Pain intensity 1.5,6 and 12 months after treatment<br /><br>- Quality of life<br /><br>- Health care use<br /><br>- Duration to resumption of daily and professional activities<br /><br>- Morbidity after treatment<br /><br>- Cross-over rate<br /><br>- Patient satisfaction<br /><br>- Cost-effectiveness