Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04623580

Flemish Inguinal and Femoral Hernia Prospective Registry

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Colette Barlé, Leuven, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical inguinal or femoral hernia repair

Device

Surgical inguinal or femoral hernia repair (primary or mesh)

Other names: Hernia repair

Primary outcomes

  1. Chronic pain after inguinal hernia repair

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Colette Ms. Barlé

CONTACT

[email protected]

++32 16 341699

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: FLIPR

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Nov 10, 2020
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.