Flemish Inguinal and Femoral Hernia Prospective Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

560 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inguinal Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Inguinal or femoral hernia repair

All consecutive inguinal or femoral hernia repair (primary or mesh)

Surgical inguinal or femoral hernia repair

Intervention Type DEVICE

Surgical inguinal or femoral hernia repair (primary or mesh)

Interventions

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Surgical inguinal or femoral hernia repair

Surgical inguinal or femoral hernia repair (primary or mesh)

Intervention Type DEVICE

Other Intervention Names

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Hernia repair

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No