Flemish Inguinal and Femoral Hernia Prospective Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical inguinal or femoral hernia repair.
- Who it may be relevant to
- Registry conditions: Inguinal Hernia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
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
- Device Surgical inguinal or femoral hernia repair
Surgical inguinal or femoral hernia repair (primary or mesh)
Primary outcome measures
- Chronic pain after inguinal hernia repair [Time frame: 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 2 centers
- UZ Leuven — Leuven
- Colette Barlé — Leuven
Identifiers
NCT: NCT04623580 · S59051