Flemish Inguinal and Femoral Hernia Prospective Registry

Universitaire Ziekenhuizen KU Leuven560 enrolled

Overview

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.

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

560

Conditions

Inguinal Hernia

Interventions

Surgical inguinal or femoral hernia repairDEVICE

Surgical inguinal or femoral hernia repair (primary or mesh)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

UZ Leuven

Leuven, Belgium

RECRUITING

Colette Barlé

Leuven, Belgium

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Central Contacts

Colette Ms. Barlé

CONTACT

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

Data from ClinicalTrials.gov

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