Flemish Inguinal and Femoral Hernia Prospective Registry

Inguinal Hernia Clinical Trial

— FLIPR  

Official title:

Flemish Inguinal and Femoral Hernia Prospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04623580
• Other study ID #: S59051
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Colette Ms. Barlé
• Phone: ++32 16 341699
• Email: colette.barle[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Femoral
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Device:
• Surgical inguinal or femoral hernia repair
Surgical inguinal or femoral hernia repair (primary or mesh)

Locations

Country	Name	City	State
Belgium	Colette Barlé	Leuven
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain after inguinal hernia repair	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.	5 years