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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06067373
Other study ID # 35-322 ex 22/23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date December 31, 2024

Study information

Verified date September 2023
Source Medical University of Graz
Contact Marianne Leitsmann, Ass.-Prof., MD
Phone +43 316 385 81582
Email marianne.leitsmann@medunigraz.at
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
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.

Locations

Country Name City State
Austria Department of Urology, Medical University Graz Graz

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 depending on the interval of the postponed surgery; through study completion, an average of 1 year
Primary 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 depending on the interval of the postponed surgery; through study completion, an average of 1 year
Secondary complication rates 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
Secondary 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 depending on the interval of the postponed surgery; through study completion, an average of 1 year
Secondary 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) depending on the interval of the postponed surgery; through study completion, an average of 1 year
Secondary general health status 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
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