No registrations found.
ID
Source
Brief title
Health condition
Inguinal Hernias
Sponsors and support
Intervention
Outcome measures
Primary outcome
PROs after inguinal hernia repair
Secondary outcome
Chronic pain after inguinal hernia repair
Background summary
Yearly, 30.000 inguinal hernia repairs are performed in the Netherlands. Surgical treatment of an inguinal hernia in successful in the majority of cases. However, 10-12% of the patients after inguinal hernia repair develop chronic pain. This has a negative impact on quality of life, daily activities and the number of days sick leave.
Discussion remains about the way of recovery and etiology of developing chronic pain after inguinal hernia repair. Patient-Reported-Outcomes Measures (PROMs) are believed to have a growing significant meaning in the treatment of any condition or disease, including inguinal hernias. However, this requires knowledges on the patient-reported-outcomes first. With the PRO-ING Study we want to study the patient-reported-outcomes after open and laparoscopic inguinal hernia surgery, and the etiology and incidence of chronic pain.
The PRO-ING Study is a multicenter prospective cohort study, that will be conducted in five hospitals in the North of the Netherlands. Patients visiting the outer patient clinic will be given the study information. In case patients want to participate an informed consent form can be returned. After surgery patients will be sent 4 follow-up questionnaires: at 6 weeks, 3 months, 6 months and 1 year. At one year follow-up, patients that have a NRS of 4 or more will be invited to the outer patient clinic for further analysis. Baseline criteria on patient characteristics, hernia specifics and operation details, together with the patient-reported-outcomes, will be collected in a database.
Study objective
The hypothesis of this study is that PROMs have a significant meaning in the management of patients undergoing inguinal hernia repair.
Study design
Start of the study: January 2019. Inclusion untill February 2020. Follow-up untill February 2021.
Intervention
Patient Reported Outcomes Measurements / Questionnaires
Inclusion criteria
Male adult patients with a primary inguinal hernia undergoing either open or laparoscopic repair
Exclusion criteria
Female, insufficient understanding of the Dutch language, recurrent hernias, emergency hernia repair
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8149 |
| Other | METC UMCG : METc 2018/500 |