Mental ImpairmentNCT06067373
Impact and Burden of Postponing Elective Surgeries
An observational study of Mental Impairment and Complication, run by Medical University of Graz at 1 site in Austria.
Trial summary
Overall, little is known about the effects and burdens of postponed operations in patients with urological diseases. To investigate the consequences and develop possible strategies for overcoming these challenges, the investigators would like to evaluate the influence of operation shifts in more detail. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Impairment, Complication
- What is being tested?
- questionnaire
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: All patients admitted to the Urology department for elective surgery are eligible for the study and, if interested, receive the patient information.
Who may be able to join
- All patients over the age of 18 attending the Department of Urology for an elective surgery
Who cannot join
- lack of ability to give consent
- emergency operations
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Urology, Medical University Graz
Graz, 8010
Marianne Leitsmann, Ass.-Prof., MD, +43 316 385 81582, marianne.leitsmann@medunigraz.at
Sascha Ahyai, Univ.-Prof., MD, +43 316 385 12508, sascha.ahyai@medunigraz.at
About this study
Official title: Impact and Burden of Postponing Elective Surgeries in Patients With Urological Diseases
Overall, little is known about the effects and burdens of postponed operations in patients with urological diseases. To investigate the consequences and develop possible strategies for overcoming these challenges, the investigators would like to evaluate the influence of operation shifts in more detail.
Read the detailed description
Medical care in Austria is struggling with staff shortages and consecutive OR (operating room) closures. The current development seems to be the result of problems that have been postponed for a long time to be accelerated by the COVID-19 pandemic. The introduction of COVID-19 vaccination and the establishment of protective measures and handling standards with infected patients made it possible to return to the regular operation. However, there is currently no noticeable improvement in the overall situation. The increasing shortage of nursing care in Austria is an increasingly urgent reason for this that affects all hospitals and care facilities. By prioritizing oncological interventions and an "oncology first" strategy at least oncological interventions and emergency interventions are performed on time. However, just looking at the waiting times for oncological interventions does not provide sufficient information of the current overall situation. The impairment for Patients with non-oncological diseases have received little attention so far given. Postponing elective surgery in patients with functional urological diseases (e.g. benign prostatic hyperplasia) can have a long-term impact on patient health and also means shifting their Surgery Burden and the stress for the patient. An American Study observed a decrease in prostate cancer diagnoses and an increase in diagnostic delays and postponements of treatments due to the pandemic, which led to greater stress and uncertainty in the affected patients.
The primary goal of this study is to record the burden on patients caused by the postponement of their surgery (mentally, physically).
Secondary outcomes include complication rates from postponement of surgery, effects on employment, awareness of the current situation (lack of care), state of health of patients upon admission to elective surgery.
- Conditions
- Mental Impairment, Complication
- Being tested
- questionnaire
- Keywords
- postponed surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
After agreeing to participate, the patients receive a questionnaire in paper form.
This consists of a total of 12 higher-level self-compiled questions as well validated survey instruments. The free questions relate, among other things, to to the surgery postponement, the associated burden, complications occurred, Effects on the employment situation, as well as the current state. The following validated survey instruments are used in the questionnaire: the NCCN Distress Thermometer to record the mental stress, a Severity Symptom Scale to record the symptom burden and the PROMIS-10 for recording the health-related life quality.
| Study group | Role | What they receive |
|---|---|---|
| patients with postponed surgery | patients with postponed surgery Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical burden caused by postponement of elective surgery
to evaluate the physical burden (e.g., scale 1-5 on severity of disease burden) caused by postponement of elective surgery
Measured: depending on the interval of the postponed surgery; through study completion, an average of 1 year
mental burden caused by postponement of elective surgery
to evaluate the mental burden (e.g., scale: NCCN-Distress thermometer, scale 1-10) caused by postponement of elective surgery
Measured: depending on the interval of the postponed surgery; through study completion, an average of 1 year
Secondary outcomes (4)
complication rates
to evaluate the frequency complications (e.g., questions on urinary retention, comparison to patient records) caused by postponement of elective surgery
Measured: depending on the interval of the postponed surgery; through study completion, an average of 1 year
effect on employment
to evaluate the effect on employment (e.g., questions about incapability to work, days of work leave, risk of getting unemployed) caused by postponement of elective surgery
Measured: depending on the interval of the postponed surgery; through study completion, an average of 1 year
awareness of the current situation
to evaluate the awareness of the current situation (e.g, knowledge about the current situation of lack of personnel and resources)
Measured: depending on the interval of the postponed surgery; through study completion, an average of 1 year
general health status
to evaluate global health status via PROMIS-10 questionnaire
Measured: depending on the interval of the postponed surgery; through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Aug 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental ImpairmentStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067373
- Sponsor's protocol ID
- 35-322 ex 22/23
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact and Burden of Postponing Elective Surgeries in Patients With Urological Diseases
- ClinicalTrials.gov ID
- NCT06067373
- Acronym / sponsor ID
- 35-322 ex 22/23
- Conditions
- Mental Impairment, Complication
- Keywords
- postponed surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Oct 2023 (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.
Overall, little is known about the effects and burdens of postponed operations in patients with urological diseases. To investigate the consequences and develop possible strategies for overcoming these challenges, the investigators would like to evaluate the influence of operation shifts in more detail.
Detailed description
Medical care in Austria is struggling with staff shortages and consecutive OR (operating room) closures. The current development seems to be the result of problems that have been postponed for a long time to be accelerated by the COVID-19 pandemic. The introduction of COVID-19 vaccination and the establishment of protective measures and handling standards with infected patients made it possible to return to the regular operation. However, there is currently no noticeable improvement in the overall situation. The increasing shortage of nursing care in Austria is an increasingly urgent reason for this that affects all hospitals and care facilities. By prioritizing oncological interventions and an "oncology first" strategy at least oncological interventions and emergency interventions are performed on time. However, just looking at the waiting times for oncological interventions does not provide sufficient information of the current overall situation. The impairment for Patients with non-oncological diseases have received little attention so far given. Postponing elective surgery in patients with functional urological diseases (e.g. benign prostatic hyperplasia) can have a long-term impact on patient health and also means shifting their Surgery Burden and the stress for the patient. An American Study observed a decrease in prostate cancer diagnoses and an increase in diagnostic delays and postponements of treatments due to the pandemic, which led to greater stress and uncertainty in the affected patients.
The primary goal of this study is to record the burden on patients caused by the postponement of their surgery (mentally, physically).
Secondary outcomes include complication rates from postponement of surgery, effects on employment, awareness of the current situation (lack of care), state of health of patients upon admission to elective surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with postponed surgery | – | Other: questionnairepatients with postponed surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the Urology department for elective surgery are eligible for the study and, if interested, receive the patient information.
Key inclusion criteria (1 listed)
- All patients over the age of 18 attending the Department of Urology for an elective surgery
Key exclusion criteria (2 listed)
- lack of ability to give consent
- emergency operations
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 |
|---|---|---|
| questionnaireAfter agreeing to participate, the patients receive a questionnaire in paper form. This consists of a total of 12 higher-level self-compiled questions as well validated survey instruments. The free questions relate, among other things, to to the surgery postponement, the associated burden, complications occurred, Effects on the employment situation, as well as the current state. The following validated survey instruments are used in the questionnaire: the NCCN Distress Thermometer to record the mental stress, a Severity Symptom Scale to record the symptom burden and the PROMIS-10 for recording the health-related life quality. | Other | patients with postponed surgery |
Primary outcome
physical burden caused by postponement of elective surgery
Time frame: depending on the interval of the postponed surgery; through study completion, an average of 1 year
to evaluate the physical burden (e.g., scale 1-5 on severity of disease burden) caused by postponement of elective surgery
mental burden caused by postponement of elective surgery
Time frame: depending on the interval of the postponed surgery; through study completion, an average of 1 year
to evaluate the mental burden (e.g., scale: NCCN-Distress thermometer, scale 1-10) caused by postponement of elective surgery
4 secondary outcomes
complication rates
Time frame: depending on the interval of the postponed surgery; through study completion, an average of 1 year
effect on employment
Time frame: depending on the interval of the postponed surgery; through study completion, an average of 1 year
awareness of the current situation
Time frame: depending on the interval of the postponed surgery; through study completion, an average of 1 year
general health status
Time frame: depending on the interval of the postponed surgery; through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Mental Impairment
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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. This study is not recruiting at the moment.
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 Mental Impairment and Complication, run by Medical University of Graz at 1 site in Austria.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Oct 2023. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne Leitsmann, Ass.-Prof., MD (+43 316 385 81582, marianne.leitsmann@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical burden caused by postponement of elective surgery (time frame: depending on the interval of the postponed surgery; through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 4 Oct 2023.