Flemish Inguinal and Femoral Hernia Prospective Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04623580

Acronym

FLIPR

Enrollment

560

Registered

2020-11-10

Start date

2018-01-01

Completion date

2028-12-31

Last updated

2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

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.

Interventions

DEVICESurgical inguinal or femoral hernia repair

Surgical inguinal or femoral hernia repair (primary or mesh)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Belgium

Contacts

Primary ContactColette Ms. Barlé

colette.barle@uzleuven.be++32 16 341699

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026