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

NCT06352710 | Recruiting

• 1 other identifier: 2022-01510
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Disc Disease; Instabilities Lumbar; Brain Tumor; Aneurysm

Keywords

Outcome; PROMs; App; Neurosurgery; Adverse event; Complication; Quality of life; TDN

Outcome Measures

Primary Outcomes (1)

• Subjective Well-Being (SWI)

  The variable of primary interest is a patient reported outcome measure (PROM), the SWI, expressing the subjective well-being of patients from 0 to 10 (0 worse, 10 best). To describe the regular postoperative course (SWI variation) after each type of surgical procedure (and according to baseline variables such as age, gender, underlying pathology, comorbidities), as well as the deviation thereof in patients who experience an AE, we will use (Generalized) Linear Mixed-effects Models (GLMMs).

  Until 2 years after study begin

Secondary Outcomes (6)

• EQ-5D-5L

  Until 2 years after study begin

• Rate of adverse events

  Until 2 years after study begin

• Severity of adverse events

  Until 2 years after study begin

• Correlation between TDN/CDG and SWI/QoL

  Until 2 years after study begin

• Correlation between baseline factors and TDN grade

  Until 2 years after study begin

Study Arms (4)

Lumbar decompression, including single- or multiple-level procedures

Other: OP-Tracker App

Lumbar transpedicular instrumentation and fusion, including extension to thorax/pelvis

Other: OP-Tracker App

Supratentorial craniotomy for tumor, vascular or other pathology

Other: OP-Tracker App

Infratentorial craniotomy for tumor, vascular or other pathology

Other: OP-Tracker App

Interventions

OP-Tracker App OTHER

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.

Infratentorial craniotomy for tumor, vascular or other pathology; 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing either one of the defined non-urgent surgical interventions on the neurocranium or the spine interested in participating in this study will be considered. Patients admitted urgently will only be considered if the surgery is not performed on the day of hospital admission, to allow for the baseline evaluation.

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

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (1)

Kantonsspital St.Gallen

Sankt Gallen, St.Gallen, 9007, Switzerland

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Aneurysm; Alzheimer Disease

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Alexis PR Terrapon, MD

CONTACT

+41 31 632 24 09; alexis.terrapon@insel.ch

Martin N Stienen, PD Dr

CONTACT

+41 71 494 77 77; martin.stienen@kssg.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Research collaborator

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: June 12, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CH (1)