Impact and Burden of Postponing Elective Surgeries

September 28, 2023 updated by: Medical University of Graz

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

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.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to the Urology department for elective surgery are eligible for the study and, if interested, receive the patient information.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 35-322 ex 22/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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