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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Switzerland
Kantonsspital St.Gallen
RECRUITING
Sankt Gallen
Contact Information
Primary
Alexis PR Terrapon, MD
alexis.terrapon@insel.ch
+41 31 632 24 09
Backup
Martin N Stienen, PD Dr
martin.stienen@kssg.ch
+41 71 494 77 77
Time Frame
Start Date: 2023-06-12
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 400
Treatments
Lumbar decompression, including single- or multiple-level procedures
Lumbar transpedicular instrumentation and fusion, including extension to thorax/pelvis
Supratentorial craniotomy for tumor, vascular or other pathology
Infratentorial craniotomy for tumor, vascular or other pathology
Related Therapeutic Areas
Sponsors
Leads: Cantonal Hospital of St. Gallen

This content was sourced from clinicaltrials.gov