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Flemish Inguinal and Femoral Hernia Prospective Registry (FLIPR)

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ClinicalTrials.gov Identifier: NCT04623580
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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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.

Condition or disease Intervention/treatment
Inguinal Hernia 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 560 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Flemish Inguinal and Femoral Hernia Prospective Registry
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain Hernia

Groups and Cohorts
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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 Name: Hernia repair


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
INGUINAL HERNIA PATIENTS
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623580


Contacts
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Contact: Colette Ms. Barlé ++32 16 341699 colette.barle@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Colette Barlé    ++32 16 341699    colette.barle@uzleuven.be   
Principal Investigator: Marc Miserez, Prof.Dr.         
Colette Barlé Recruiting
Leuven, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04623580    
Other Study ID Numbers: S59051
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Hernia, Femoral
Pathological Conditions, Anatomical
Hernia, Abdominal