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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UZ Leuven
Leuven, Belgium
Colette Barlé
Leuven, Belgium
Start Date
January 1, 2018
Primary Completion Date
December 31, 2028
Completion Date
December 31, 2028
Last Updated
July 1, 2024
560
ESTIMATED participants
Surgical inguinal or femoral hernia repair
DEVICE
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
NCT07461558
NCT07423910
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07181876