Flemish Inguinal and Femoral Hernia Prospective Registry

ConditionInguinal Hernia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Younger than 18 years

Not operated or supervised by participating surgeon

Pregnant at inclusion in the registry

No signed informed consent form

Trial population

INGUINAL HERNIA PATIENTS

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Surgical inguinal or femoral hernia repair
Device
Surgical inguinal or femoral hernia repair (primary or mesh)

Treatment groups

560 Participants

are divided into 1 treatment group

Group A: Inguinal or femoral hernia repair1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov

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