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ID
Source
Brief title
Health condition
Inguinal hernia
Sponsors and support
Intervention
Outcome measures
Primary outcome
CPIP (chronic postoperative inguinal pain) 3 months post operative
Secondary outcome
Surgical site infection, return to work / daily activities
Background summary
Patient Reported Outcomes have become standard in the evaluation of inguinal hernia repair. However, the chosen outcomes remain heterogeneous, the measurements time-consuming or inadequate. Perioperative measurement of pain and recovery could benefit from the contemporary possibilities that mobile health applications offer.
An application for smartphones and tablets was developed using the twitch crowdsourcing concept, classical questionnaires, experiences from randomised clinical trials and patients’ input.
Dichotomous questions and numeric rating scales, both pre- and postoperative, were implemented in the freely available Q1.6 application. Content, timing and frequencies were adapted to the inguinal hernia patient’s daily life and assumed recovery. Certain combinations of answers were set as alert notifications to detect adverse events. Data is displayed on a web-based dashboard enabling real-time monitoring. Legal aspects were examined and taken into account.
The Q1.6 inguinal hernia app is an innovative tool for perioperative monitoring of pain and recovery of inguinal hernia patients. Previous limitations of classical measurements such as a large heterogeneity, retrospective data recording and different forms of bias can be eliminated. The `big data´ generated in this manner might be used for large-scale research to improve inguinal hernia surgery. A pilot study was performed to test the feasibility of the application and generated data even as the use in daily clinical practice for patients as well as physicians
Study objective
Inguinal hernia application provides real-time monitoring. It also might provide more accurate, more reliable and more extensive data on recovery after surgery. Patients are questioned in a less intrusive way, leading to more compliance en less missing data or others forms of bias which are encountered with classical paper questionnaires
Study design
Every day (postoperative day 1-14), every week (POD 15-90), every month (post operative month 4-12)
Intervention
Pilot patients install the application prior to inguinal hernia surgery and are advised to use it 1 yr postoperatively
Inclusion criteria
Primairy inguinal hernia, adult, Dutch language, no cognitive impairment, in possession of smartphone or tablet with Android or iOS operating system
Exclusion criteria
Previous inguinal (hernia) surgery, < 18 yr, insufficient language (Dutch) skills, cognitive impairment
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL7813 |
Other | METC Brabant : NW2016-36 |