NCT04623580

Flemish Inguinal and Femoral Hernia Prospective Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 560 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
DEVICE	Surgical inguinal or femoral hernia repair	Surgical inguinal or femoral hernia repair (primary or mesh)

Timeline

• Start date: 2018-01-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2020-11-10
• Last updated: 2024-07-01

Locations

2 sites across 1 country: Belgium

Regulatory

• FDA-regulated device study