Impact and Burden of Postponing Elective Surgeries

Complication Clinical Trial

Official title:

Impact and Burden of Postponing Elective Surgeries in Patients With Urological Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067373
• Other study ID #: 35-322 ex 22/23
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Complication
• Mental Impairment

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