Flemish Inguinal and Femoral Hernia Prospective Registry

Recruiting

• Conditions: Inguinal Hernia

• 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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.

Trial Locations

Locations (2)

UZ Leuven; 🇧🇪 Leuven, Belgium

Colette Barlé; 🇧🇪 Leuven, Belgium