- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06067373
Impact and Burden of Postponing Elective Surgeries
Impact and Burden of Postponing Elective Surgeries in Patients With Urological Diseases
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marianne Leitsmann, Ass.-Prof., MD
- Phone Number: +43 316 385 81582
- Email: marianne.leitsmann@medunigraz.at
Study Contact Backup
- Name: Iva Simunovic, MD
- Phone Number: +43 316 385 81963
- Email: iva.simunovic@medunigraz.at
Study Locations
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Graz, Austria, 8010
- Recruiting
- Department of Urology, Medical University Graz
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Contact:
- Marianne Leitsmann, Ass.-Prof., MD
- Phone Number: +43 316 385 81582
- Email: marianne.leitsmann@medunigraz.at
-
Contact:
- Sascha Ahyai, Univ.-Prof., MD
- Phone Number: +43 316 385 12508
- Email: sascha.ahyai@medunigraz.at
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients over the age of 18 attending the Department of Urology for an elective surgery
Exclusion Criteria:
- lack of ability to give consent
- emergency operations
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients with postponed surgery
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
depending on the interval of the postponed surgery; through study completion, an average of 1 year
|
|
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
|
depending on the interval of the postponed surgery; through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
complication rates
Time Frame: depending on the interval of the postponed surgery; through study completion, an average of 1 year
|
to evaluate the frequency complications (e.g., questions on urinary retention, comparison to patient records) caused by postponement of elective surgery
|
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
|
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
|
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
|
to evaluate the awareness of the current situation (e.g, knowledge about the current situation of lack of personnel and resources)
|
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
|
to evaluate global health status via PROMIS-10 questionnaire
|
depending on the interval of the postponed surgery; through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 35-322 ex 22/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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