Impact and Burden of Postponing Elective Surgeries

NCT ID: NCT06067373

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-12-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with postponed surgery

patients with postponed surgery

questionnaire

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Urology, Medical University Graz

Graz, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Marianne Leitsmann, Ass.-Prof., MD

Role: CONTACT

marianne.leitsmann@medunigraz.at

+43 316 385 81582

Iva Simunovic, MD

Role: CONTACT

iva.simunovic@medunigraz.at

+43 316 385 81963

Facility Contacts

Marianne Leitsmann, Ass.-Prof., MD

Role: primary

marianne.leitsmann@medunigraz.at

+43 316 385 81582

Sascha Ahyai, Univ.-Prof., MD

Role: backup

sascha.ahyai@medunigraz.at

+43 316 385 12508

Other Identifiers

35-322 ex 22/23

Identifier Type: -

Identifier Source: org_study_id