Flemish Inguinal and Femoral Hernia Prospective Registry (FLIPR)

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Device: Surgical inguinal or femoral hernia repair

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 Type: Observational
• Enrollment (Estimated): 560

Contacts and Locations

• Study Contact: Name: Colette Ms. Barlé; Phone Number: ++32 16 341699; Email: colette.barle@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Colette Barlé; Phone Number: ++32 16 341699; Email: colette.barle@uzleuven.be
    • Principal Investigator: Marc Miserez, Prof.Dr.
  • Leuven, Belgium
    • Recruiting
    • Colette Barlé

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

INGUINAL HERNIA PATIENTS

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inguinal or femoral hernia repair; All consecutive inguinal or femoral hernia repair (primary or mesh)	Device: Surgical inguinal or femoral hernia repair; Surgical inguinal or femoral hernia repair (primary or mesh); Other Names: Hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Hernia, Femoral
• Other Study ID Numbers: S59051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes