Flemish Inguinal and Femoral Hernia Prospective Registry
- Conditions
- Inguinal Hernia
- Interventions
- Device: Surgical inguinal or femoral hernia repair
- Registration Number
- NCT04623580
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
Prospective registry. The purpose of this clinical trial will be to measure surgical outcome parameters (e.g. recurrence, chronic pain and other quality indicators) after inguinal hernia repair using Patient Reported Outcome Measures (PROMs) in the short- and long-term.
- Detailed Description
The primary objective is to investigate moderate to severe chronic pain 1 year after inguinal or femoral hernia repair, defined as numeric rating scale (NRS) ≥ 4, during daily activities.
The secondary objectives are:
* Surgical Site Occurrence (SSO) after 30 days
* Scope and incidence of pre- and postoperative pain (NRS 0 to 10)
* The difference between pre- and postoperative NRS scores (relative NRS score)
* Presence of pain and impact of pain on daily life activities
* Satisfaction and quality of life
* Sexual function
* Anxiety and depression
* Catastrophizing
* Recurrence
* Development of a predictive model for chronic pain.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 560
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Inguinal or femoral hernia repair Surgical inguinal or femoral hernia repair All consecutive inguinal or femoral hernia repair (primary or mesh)
- Primary Outcome Measures
Name Time Method Chronic pain after inguinal hernia repair 5 years To investigate moderate to severe chronic pain 1 year after inguinal or femoral hernia repair, defined as numeric rating scale (NRS) ≥ 4, during daily activities.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Colette Barlé
🇧🇪Leuven, Belgium
UZ Leuven
🇧🇪Leuven, Belgium