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

Recruiting now

Conditions studied: Disc Disease, Instabilities Lumbar, Brain Tumor, Aneurysm

In brief

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.

Key facts

Study ID

NCT06352710

Run by

Cantonal Hospital of St. Gallen

People needed

400

Starts

2023-06-12

Expected to finish

2027-12-31

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• The patient must be able to consent
• The patient is willing to provide data upon one year after surgery
• The patient possesses and is capable of using a smartphone (Android or iOS operative systems)
• The patient has the necessary language and cognitive skills to use the smartphone app
• The patient is scheduled for one of the defined operations (see above for both spinal and cranial) and in a stable, non-life-threatening situation (admitted to the regular ward or intermediate care unit (IMC))
• Baseline preoperative SWI and QoL assessment is possible (minimum requirement is one assessment, the latest the day before surgery)

You may not qualify if…

• Pregnancy
• Foreseeable difficulties using the smartphone or smartphone app
• The presence of a condition that hinders the baseline preoperative assessment
• Health conditions that render inclusion unsafe (e.g., untreated ruptured intracranial aneurysm or congestive heart failure; in general, all patients admitted to the intensive care unit (ICU))

Where it is running

• Kantonsspital St.Gallen — Sankt Gallen, St.Gallen, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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