Registry for inguinal and femoral hernia surgical outcomes
Flemish Inguinal and Femoral Hernia Prospective Registry
This study is trying to see how well surgery for inguinal and femoral hernias works by looking at pain levels and patient satisfaction one year after the operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 560 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 2 sites (Leuven and 1 other locations) |
| Trial ID | NCT04623580 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective registry aimed at measuring surgical outcome parameters following inguinal and femoral hernia repair. It focuses on assessing moderate to severe chronic pain one year post-surgery, using Patient Reported Outcome Measures (PROMs). Secondary objectives include evaluating surgical site occurrences, pre- and postoperative pain levels, patient satisfaction, quality of life, and the development of a predictive model for chronic pain. The study will involve patients operated on by participating surgeons since January 1, 2018.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with inguinal or femoral hernias who have undergone surgery by participating surgeons since 2018.
Not a fit: Patients under 18, those not operated on by participating surgeons, or pregnant individuals may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of chronic pain outcomes and enhance postoperative care for hernia repair patients.
How similar studies have performed: Other studies have shown success in evaluating surgical outcomes and chronic pain in hernia repairs, making this approach well-supported by existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Consecutively all patients with a groin hernia (inguinal and/or femoral hernia) operated starting 01.01.2018. * Male and female * 18 years or older * Operated of supervised by a participating surgeon (participating in this study is not necessarily by a whole surgical department of a hospital, but by specific surgeons) * Elective and emergency surgery * Primary and recurrent hernia * Metachronous and synchronous hernia * Signed informed consent form Exclusion criteria * Younger than 18 years * Not operated or supervised by participating surgeon * Pregnant at inclusion in the registry * No signed informed consent form
Where this trial is running
Leuven and 1 other locations
- UZ Leuven — Leuven, Belgium (Recruiting)
- Colette Barlé — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Colette Ms. Barlé
- Email: colette.barle@uzleuven.be
- Phone: ++32 16 341699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.