Disc DiseaseNCT06352710
Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment
An observational study of Disc Disease and Instabilities Lumbar, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disc Disease, Instabilities Lumbar, Brain Tumor
- What is being tested?
- OP-Tracker App
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Jun 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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))
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital St.Gallen
Sankt Gallen, St.Gallen, 9007
Linda Bättig, MD, +41 71 494 11 99, linda.baettig@kssg.ch
About this study
Official title: Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project
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.
Read the detailed description
Understanding and analyzing the impact of surgery and adverse events (AEs) on the subjective well-being of patients is of paramount importance as it provides objective information that may be useful in a risk-benefit discussion. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. This results in a poor understanding of the normal postoperative course which in turn prevents consistent reporting of AEs as they are usually defined as a deviation thereof. As an additional challenge and because there is no consensus and/or recommendation on this subject, AEs are graded using various classifications that neglect the impact of AEs on the subjective well-being of patients. For example, the most used AE grading system is the therapy-based Clavien-Dindo-Grading system (CDG, doi:10.1097/01.sla.0000133083.54934.ae), which fails to detect the severity of AE that are not treated by means of pharmacotherapy and/or surgery. This is an important limitation as new neurologic deficits are frequent AEs that may imply dramatic consequences on quality of life but are considered as low grade in therapy-based grading systems such as the CDG. Other classifications were developed specifically for neurosurgery but they suffer the same limitations. Recently, our group proposed the Therapy-Disability-Neurology Grade (TDN, doi:10.1093/neuros/nyab121) to address this problem. The TDN grade takes into account the therapy used to counteract AEs (as does the CDG), the associated neurologic deficits, and the resulting disability, but currently lacks widespread use and validation. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of quality of the treatment delivered.
The increasing use of smartphones across all age groups offers unprecedented opportunities for data collection. The investigators have created a smartphone application (app) to assess patient well-being in a standardized and longitudinal fashion. The app named "Op-tracker app". It collects longitudinal, self-reported data (subjective well-being rated from 0 to 10) at fixed time points before and after surgery. Additional information such as type of disease, type of surgery (currently four categories), AE description and severity (according to the CDG and TDN grade) is also recorded, along with a standardized quality of life (QoL) questionnaire (EQ-5D-5L). A simplified version recently described in a feasibility study showed good acceptance and no major technical issues (doi:10.1007/s00701-021-04967-0). With this innovative technique of data acquisition, The investigators will gather a higher density of data using less resources than traditional methods.
In a prospective observational pilot study without intervention using the "op-tracker app" to acquire longitudinal patient reported outcome measures (the subjective well-being index, SWI) before and after surgery, the investigators aim to determine the regular postoperative course for certain surgical procedures as well as the deviation thereof depending on the severity of specific AEs. The investigators will evaluate the validity of existing AE severity grading systems and if necessary, propose a classification more consistent with the subjective well-being of patients. This will greatly benefit patient information by providing essential insight about standard and complicated postoperative course. Beyond the benefit this new data will add to the scientific literature, the investigators hope that the app will improve daily patient care by enabling early detection of and reaction to AEs in case of "pathological decrease" in self-reported well-being and QoL. Should this be confirmed, the app could be widely used and its scope could be extended to the whole neurosurgical spectrum or even to further surgical subspecialties. The investigators anticipate that this will result in an increase in standardized reporting of patient outcome and ultimately in a more evidence-based patient information and decision-making.
- Conditions
- Disc Disease, Instabilities Lumbar, Brain Tumor, Aneurysm
- Being tested
- OP-Tracker App
- Keywords
- Outcome, PROMs, App, Neurosurgery, Adverse event, Complication, Quality of life, TDN
- Medical subject headings
- Brain Neoplasms, Aneurysm, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OP-Tracker AppOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar decompression, including single- or multiple-level procedures | Not described Receives: Other: OP-Tracker App | |
| Lumbar transpedicular instrumentation and fusion, including extension to thorax/pelvis | Not described Receives: Other: OP-Tracker App | |
| Supratentorial craniotomy for tumor, vascular or other pathology | Not described Receives: Other: OP-Tracker App | |
| Infratentorial craniotomy for tumor, vascular or other pathology | Not described Receives: Other: OP-Tracker App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Until 2 years after study begin
Secondary outcomes (6)
EQ-5D-5L
The difference in standardized QoL questionnaire (EQ-5D-5L) before as compared to 3 and 12 months after an operation (as well as sub-analysis for each type of surgery and with vs without an AE).
Measured: Until 2 years after study begin
Rate of adverse events
The difference in the rate of AEs in the first year after surgery between different types of surgery.
Measured: Until 2 years after study begin
Severity of adverse events
The difference in the distribution of the severity (using the CDG and TDN grade, 1-5 scale, 1 best, 5 worse) of AEs in the first year after surgery between different types of surgery.
Measured: Until 2 years after study begin
Correlation between TDN/CDG and SWI/QoL
The correlation between the severity of AEs in the first year after surgery (using the CDG system and the TDN grade) and postoperative SWI and QoL (EQ-5D-5L).
Measured: Until 2 years after study begin
Correlation between baseline factors and TDN grade
The relationship between patient-specific variables (e.g., age, sex, etc.) and the rate as well as severity of AEs in the first year after surgery.
Measured: Until 2 years after study begin
Difference between rate of adverse events and TDN distribution between different surgery groups
The difference in the rate and severity of AEs in the first year after surgery for different groups of patients (for example according to underlying pathology, other medical conditions, or a combination of such factors).
Measured: Until 2 years after study begin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start12 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis P. R. Terrapon, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352710
- Sponsor's protocol ID
- 2022-01510
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project
- ClinicalTrials.gov ID
- NCT06352710
- Acronym / sponsor ID
- 2022-01510
- Conditions
- Disc Disease, Instabilities Lumbar, Brain Tumor, Aneurysm
- Keywords
- Outcome, PROMs, App, Neurosurgery, Adverse event, Complication, Quality of life, TDN
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Understanding and analyzing the impact of surgery and adverse events (AEs) on the subjective well-being of patients is of paramount importance as it provides objective information that may be useful in a risk-benefit discussion. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. This results in a poor understanding of the normal postoperative course which in turn prevents consistent reporting of AEs as they are usually defined as a deviation thereof. As an additional challenge and because there is no consensus and/or recommendation on this subject, AEs are graded using various classifications that neglect the impact of AEs on the subjective well-being of patients. For example, the most used AE grading system is the therapy-based Clavien-Dindo-Grading system (CDG, doi:10.1097/01.sla.0000133083.54934.ae), which fails to detect the severity of AE that are not treated by means of pharmacotherapy and/or surgery. This is an important limitation as new neurologic deficits are frequent AEs that may imply dramatic consequences on quality of life but are considered as low grade in therapy-based grading systems such as the CDG. Other classifications were developed specifically for neurosurgery but they suffer the same limitations. Recently, our group proposed the Therapy-Disability-Neurology Grade (TDN, doi:10.1093/neuros/nyab121) to address this problem. The TDN grade takes into account the therapy used to counteract AEs (as does the CDG), the associated neurologic deficits, and the resulting disability, but currently lacks widespread use and validation. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of quality of the treatment delivered.
The increasing use of smartphones across all age groups offers unprecedented opportunities for data collection. The investigators have created a smartphone application (app) to assess patient well-being in a standardized and longitudinal fashion. The app named "Op-tracker app". It collects longitudinal, self-reported data (subjective well-being rated from 0 to 10) at fixed time points before and after surgery. Additional information such as type of disease, type of surgery (currently four categories), AE description and severity (according to the CDG and TDN grade) is also recorded, along with a standardized quality of life (QoL) questionnaire (EQ-5D-5L). A simplified version recently described in a feasibility study showed good acceptance and no major technical issues (doi:10.1007/s00701-021-04967-0). With this innovative technique of data acquisition, The investigators will gather a higher density of data using less resources than traditional methods.
In a prospective observational pilot study without intervention using the "op-tracker app" to acquire longitudinal patient reported outcome measures (the subjective well-being index, SWI) before and after surgery, the investigators aim to determine the regular postoperative course for certain surgical procedures as well as the deviation thereof depending on the severity of specific AEs. The investigators will evaluate the validity of existing AE severity grading systems and if necessary, propose a classification more consistent with the subjective well-being of patients. This will greatly benefit patient information by providing essential insight about standard and complicated postoperative course. Beyond the benefit this new data will add to the scientific literature, the investigators hope that the app will improve daily patient care by enabling early detection of and reaction to AEs in case of "pathological decrease" in self-reported well-being and QoL. Should this be confirmed, the app could be widely used and its scope could be extended to the whole neurosurgical spectrum or even to further surgical subspecialties. The investigators anticipate that this will result in an increase in standardized reporting of patient outcome and ultimately in a more evidence-based patient information and decision-making.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OP-Tracker AppThere 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. | Other | 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 |
Primary outcome
Subjective Well-Being (SWI)
Time frame: Until 2 years after study begin
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).
6 secondary outcomes
EQ-5D-5L
Time frame: Until 2 years after study begin
Rate of adverse events
Time frame: Until 2 years after study begin
Severity of adverse events
Time frame: Until 2 years after study begin
Correlation between TDN/CDG and SWI/QoL
Time frame: Until 2 years after study begin
Correlation between baseline factors and TDN grade
Time frame: Until 2 years after study begin
Difference between rate of adverse events and TDN distribution between different surgery groups
Time frame: Until 2 years after study begin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disc Disease and Instabilities Lumbar, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis PR Terrapon, MD (+41 31 632 24 09, alexis.terrapon@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Well-Being (SWI) (time frame: Until 2 years after study begin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.