NCT06352710 Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment
| NCT ID | NCT06352710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cantonal Hospital of St. Gallen |
| Condition | Disc Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-06-12 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-06-12 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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))
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06352710 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Disc Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06352710 currently recruiting?
Yes, NCT06352710 is actively recruiting participants. Contact the research team at alexis.terrapon@insel.ch for enrollment information.
Where is the NCT06352710 trial being conducted?
This trial is being conducted at Sankt Gallen, Switzerland.
Who is sponsoring the NCT06352710 clinical trial?
NCT06352710 is sponsored by Cantonal Hospital of St. Gallen. The trial plans to enroll 400 participants.