Actively Recruiting
Flemish Inguinal and Femoral Hernia Prospective Registry
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
560
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating surgical outcomes after inguinal or femoral hernia repair by measuring patient-reported outcomes related to pain, quality of life, and other recovery indicators. The main focus is to understand moderate to severe chronic pain one year after surgery during daily activities, along with other factors such as surgical site occurrences, recurrence, and psychological impacts like anxiety and depression. The study involves patients undergoing surgical repair of inguinal or femoral hernias, including both primary and mesh repairs. All patients operated on or supervised by participating surgeons are included, covering elective and emergency surgeries as well as primary, recurrent, metachronous, and synchronous hernias. This prospective registry collects data on pain levels and other quality indicators before and after surgery. Participants will provide information through patient-reported outcome measures at various times, allowing researchers to assess pain, satisfaction, sexual function, and mental health aspects. The study aims to develop a predictive model for chronic pain after hernia repair. The follow-up includes monitoring chronic pain over a period of five years and other postoperative outcomes. Participation requires signed informed consent, and data collection supports understanding of long-term surgical results.
CONDITIONS
Brief Title
Flemish Inguinal and Femoral Hernia Prospective Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a groin hernia (inguinal and/or femoral) operated starting 01.01.2018
- Male and female
- 18 years or older
- Surgery performed or supervised by a participating surgeon
- Includes elective and emergency surgery
- Includes primary and recurrent hernia
- Includes metachronous and synchronous hernia
- Signed informed consent form
You will not qualify if you...
- Younger than 18 years
- Surgery not performed or supervised by a participating surgeon
- Pregnant at inclusion in the registry
- No signed informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery plus initial recovery period
Participants undergo surgical inguinal or femoral hernia repair and receive immediate post-operative care.
1 surgery visit and immediate post-operative assessments
Duration - Up to 5 years
Participants are followed up to assess surgical site occurrence, pain levels, quality of life, and other outcomes.
Multiple visits over 5 years for pain assessment and follow-up
Trial Site Locations
Total: 2 locations
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
2
Colette Barlé
Leuven, Belgium
Actively Recruiting
Research Team
C
Colette Ms. Barlé
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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