Inguinal HerniaFLIPRNCT04623580
Flemish Inguinal and Femoral Hernia Prospective Registry
An observational study of Inguinal Hernia, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Surgical inguinal or femoral hernia repair
- Type of treatment
- Medical device
- How many people
- 560 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Jan 2018to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: INGUINAL HERNIA PATIENTS
Who may be able to join
- 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
Who cannot join
- Younger than 18 years
- Not operated or supervised by participating surgeon
- Pregnant at inclusion in the registry
- No signed informed consent form
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Colette Barlé, ++32 16 341699, colette.barle@uzleuven.be
Marc Miserez, Prof.Dr.
- Recruiting
Colette Barlé
Leuven
About this study
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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Surgical inguinal or femoral hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical inguinal or femoral hernia repairDevice
Also called Hernia repair
Surgical inguinal or femoral hernia repair (primary or mesh)
| Study group | Role | What they receive |
|---|---|---|
| Inguinal or femoral hernia repair | All consecutive inguinal or femoral hernia repair (primary or mesh) Receives: Device: Surgical inguinal or femoral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 560 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623580
- Sponsor's protocol ID
- S59051
- Acronym
- FLIPR
- Status last verified
- Jun 2024
- First submitted
- 5 Nov 2020
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flemish Inguinal and Femoral Hernia Prospective Registry
- ClinicalTrials.gov ID
- NCT04623580
- Acronym / sponsor ID
- FLIPR / S59051
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inguinal or femoral hernia repair | – | Device: Surgical inguinal or femoral hernia repairAll consecutive inguinal or femoral hernia repair (primary or mesh) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- INGUINAL HERNIA PATIENTS
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Younger than 18 years
- Not operated or supervised by participating surgeon
- Pregnant at inclusion in the registry
- No signed informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical inguinal or femoral hernia repairAlso: Hernia repairSurgical inguinal or femoral hernia repair (primary or mesh) | Device | Inguinal or femoral hernia repair |
Primary outcome
Chronic pain after inguinal hernia repair
Time frame: 5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colette Ms. Barlé (++32 16 341699, colette.barle@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain after inguinal hernia repair (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.