Impact and Burden of Postponing Elective Surgeries

Sponsor
Medical University of Graz (Other)
Overall Status
Recruiting
CT.gov ID
NCT06067373
Collaborator
(none)
100
1
17
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire

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

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact and Burden of Postponing Elective Surgeries in Patients With Urological Diseases
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
patients with postponed surgery

patients with postponed surgery

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.

Outcome Measures

Primary Outcome Measures

  1. physical burden caused by postponement of elective surgery [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

  2. mental burden caused by postponement of elective surgery [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

Secondary Outcome Measures

  1. complication rates [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

  2. effect on employment [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

  3. awareness of the current situation [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)

  4. general health status [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Urology, Medical University Graz Graz Austria 8010

Sponsors and Collaborators

  • Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT06067373
Other Study ID Numbers:
  • 35-322 ex 22/23
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Medical University of Graz

Study Results

No Results Posted as of Oct 4, 2023