Flemish Inguinal and Femoral Hernia Prospective Registry (FLIPR)

Universitaire Ziekenhuizen KU Leuven

Status

Enrolling

Conditions

Inguinal Hernia

Treatments

Device: Surgical inguinal or femoral hernia repair

Study type

Observational

Funder types

Other

Identifiers

NCT04623580

S59051

Details and patient eligibility

About

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.

Full 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.

Enrollment

560 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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