NCT04623580

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Jan 2018Dec 2028

Study Start

First participant enrolled

January 1, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

11 years

First QC Date

November 5, 2020

Last Update Submit

June 28, 2024

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Inguinal or femoral hernia repair

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

Device: Surgical inguinal or femoral hernia repair

Interventions

Surgical inguinal or femoral hernia repairDEVICE

Surgical inguinal or femoral hernia repair (primary or mesh)

Also known as: Hernia repair
Inguinal or femoral hernia repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

INGUINAL HERNIA PATIENTS

You may qualify if:

  • Consecutively all patients with a groin hernia (inguinal and/or femoral hernia) operated starting 01.01.2018.
  • Male and female
  • 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

You may not qualify if:

  • Younger than 18 years
  • Not operated or supervised by participating surgeon
  • No signed informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Colette Barlé

Leuven, Belgium

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Herniorrhaphy

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Central Study Contacts

Colette Ms. Barlé

CONTACT

++32 16 341699colette.barle@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 10, 2020

Study Start

January 1, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 1, 2024

Record last verified: 2024-06

Locations

BE(2)