Actively Recruiting
Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project
Led by Cantonal Hospital of St. Gallen · Updated on 2026-03-19
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the impact of surgery and adverse events (AEs) on patients' subjective well-being after neurosurgical procedures. The study aims to improve outcome research by using a smartphone app to collect patient-reported data before and after surgery. Current methods are limited by static data collection, missing information, and inconsistent AE grading systems that do not fully capture patient experiences. This research seeks to evaluate existing AE classifications and propose a patient-centered approach to better understand recovery and complications. Participants will use the OP-Tracker App on their smartphones to report their well-being, AE details, and quality of life at specified times before and after surgery. The app collects data such as the type of surgery, AE severity according to two grading systems (Clavien-Dindo-Grading and Therapy-Disability-Neurology Grade), and standardized quality of life questionnaires. The app adjusts the frequency of well-being assessments based on any reported AEs and allows patients to report events at any time. The study includes various neurosurgical procedures like lumbar decompression, spinal fusion, and craniotomies. During the study, participants will complete daily well-being ratings and quality of life assessments at baseline, 3 months, and 12 months after surgery. Researchers will analyze these patient-reported outcomes to determine typical recovery patterns and how adverse events affect well-being over time. The study will monitor the rate and severity of AEs, correlate grading systems with patient well-being, and compare outcomes across surgery types. This observational study is expected to last up to two years, providing valuable insights into postoperative recovery and patient experiences.
CONDITIONS
Brief Title
Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to provide informed consent
- Willingness to provide data for one year after surgery
- Possession of and ability to use a smartphone with Android or iOS
- Necessary language and cognitive skills to use the smartphone app
- Scheduled for one of the defined spinal or cranial neurosurgical operations
- Stable, non-life-threatening condition (admitted to regular ward or intermediate care unit)
- Ability to complete baseline preoperative well-being and quality of life assessment (at least one assessment before surgery)
You will not qualify if you...
- Pregnancy
- Expected difficulties in using the smartphone or app
- Conditions preventing baseline preoperative assessment
- Health conditions making participation unsafe (e.g., untreated ruptured intracranial aneurysm, congestive heart failure, intensive care unit admission)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Up to 2 years after surgery
Participants use the OP-Tracker App to report their subjective well-being and register any adverse events before and after neurosurgery. The app collects daily self-reported well-being scores and quality of life assessments at specified time points.
Daily self-reports before and after surgery; quality of life questionnaires at baseline, 3 months, and 12 months after surgery
Trial Site Locations
Total: 1 location
1
Kantonsspital St.Gallen
Sankt Gallen, St.Gallen, Switzerland, 9007
Actively Recruiting
Research Team
A
Alexis PR Terrapon, MD
M
Martin N Stienen, PD Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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