Flemish Inguinal and Femoral Hernia Prospective Registry | NCT04623580

Studies
Flemish Inguinal and Femoral Hernia Prospective Registry

NCT04623580

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Recruiting

Last Update Posted

Jul 1, 2024Actual

Enrollment

560Estimated

Phase

Not provided

Conditions

Inguinal Hernia

Interventions

Surgical inguinal or femoral hernia repair

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Nov 5, 2020

First Submission Date that Met QC Criteria

Nov 5, 2020

First Posted Date

Nov 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2024

Last Update Posted Date

Jul 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

560Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inguinal or femoral hernia repair		All consecutive inguinal or femoral hernia repair (primary or mesh)	Device: Surgical inguinal or femoral hernia repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical inguinal or femoral hernia repair	Device	Surgical inguinal or femoral hernia repair (primary or mesh)	Inguinal or femoral hernia repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

INGUINAL HERNIA PATIENTS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Colette Ms. Barlé	Contact	++32 16 341699		colette.barle@uzleuven.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven	Recruiting	Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059685	Herniorrhaphy

Ancestor Terms

ID	Term
D019651	Plastic Surgery Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided