Actively Recruiting

Age: 18Years +
All Genders
NCT06352710

Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment

Led by Cantonal Hospital of St. Gallen · Updated on 2026-03-19

400

Participants Needed

1

Research Sites

237 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Analyzing the impact of surgery and adverse events (AEs) on patients' well-being is of paramount importance as it provides essential information for benefit-risk assessment. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. Moreover, AEs are inconsistently reported using various grading systems that usually do not account for patients' subjective well-being. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of treatment quality. The increasing use of smartphones offers unprecedented opportunities for data collection. The investigators developed a free smartphone application to assess fluctuations of patients' well-being as a result of surgical treatment and possible AEs. The application is installed on each patient's smartphone and collects standardized data at defined timepoints before and after surgery (well-being, AE description and severity). By acquiring longitudinal patient-reported outcome before and after neurosurgical interventions, the investigators aim to determine the regular postoperative course for specific surgical procedures, as well as any deviation thereof, depending on the occurrence and severity of AEs. The investigators will evaluate the validity of existing AE classifications and, if necessary, propose a new patient-centered scheme. The investigators hope that this will result in an increase in standardized reporting of patient outcome, and ultimately allow for evidence-based patient information and decision-making.

CONDITIONS

Official Title

Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 26 18 years
  • Ability to give consent
  • Willingness to provide data for one year after surgery
  • Possession and ability to use a smartphone (Android or iOS)
  • Adequate language and cognitive skills to use the app
  • Scheduled for one of the defined spinal or cranial surgeries in a stable, non-life-threatening condition (regular ward or intermediate care unit)
  • Ability to complete baseline preoperative well-being and quality of life assessment (at least one assessment before surgery)
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Anticipated difficulties using the smartphone or app
  • Conditions preventing baseline preoperative assessment
  • Health issues making participation unsafe (e.g., untreated ruptured intracranial aneurysm, congestive heart failure, admission to intensive care unit)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Kantonsspital St.Gallen

Sankt Gallen, St.Gallen, Switzerland, 9007

Actively Recruiting

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Research Team

A

Alexis PR Terrapon, MD

CONTACT

M

Martin N Stienen, PD Dr

CONTACT

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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Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment | DecenTrialz