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

NCT06352710 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-03-19

No results posted yet for this study

Summary

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

  • Disc Disease
  • Instabilities Lumbar
  • Brain Tumor
  • Aneurysm

Interventions

OTHER

OP-Tracker App

There will be no study-specific therapeutic intervention. The OP-Tracker App will be downloaded and installed on the patient's smartphone. Preoperative assessment: baseline factors such as age, gender, medical conditions, type of disease and of surgery, EQ-5D-5L. Before and after surgery surgery, SWI (Quality of life) will be assessed daily using "pop-ups"; the patient will input the value (0-10) using a slide-bar. After completion of the surgery, the app will automatically modify the number of SWI assessments over time according to the occurrence of AEs. At any point in time, the patient will be able to register an AE in the smartphone app. The patient can select the AE via a drop-down menu in the app, and can additionally input free text in case of an AE of type "other". Using a further drop-down menu, the patient will classify the AE according to the CDG and TDN grade. QoL assessments (EQ-5D-5L questionnaire) will pop up before, and at 3 and 12 months after surgery.

Sponsors & Collaborators

  • Cantonal Hospital of St. Gallen

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06352710 on ClinicalTrials.gov