The hypothesis of this study is that PROMs have a significant meaning in the management of patients undergoing inguinal hernia repair.
ID
Bron
Verkorte titel
Aandoening
Inguinal Hernias
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
PROs after inguinal hernia repair
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The hypothesis of this study is that PROMs have a significant meaning in the management of patients undergoing inguinal hernia repair.
Onderzoeksopzet
Start of the study: January 2019. Inclusion untill February 2020. Follow-up untill February 2021.
Onderzoeksproduct en/of interventie
Patient Reported Outcomes Measurements / Questionnaires
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Male adult patients with a primary inguinal hernia undergoing either open or laparoscopic repair
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Female, insufficient understanding of the Dutch language, recurrent hernias, emergency hernia repair
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiƫnten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL8149 |
Ander register | METC UMCG : METc 2018/500 |