NCT06352710Recruiting
Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment
Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 2 Apr 2024
- Start date
- 12 Jun 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Cantonal Hospital of St. Gallen
- NCT number
- NCT06352710
What you commit to
- Study type: Observational
- Planned participants: 400
- From 12 Jun 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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))
Other
- Pregnancy
- Foreseeable difficulties using the smartphone or smartphone app
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.