Impact and Burden of Postponing Elective Surgeries

NCT06067373 | Unknown

• 1 other identifier: 35-322 ex 22/23
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Impairment; Complication

Keywords

postponed surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• complication rates

  depending on the interval of the postponed surgery; through study completion, an average of 1 year

• effect on employment

  depending on the interval of the postponed surgery; through study completion, an average of 1 year

• awareness of the current situation

  depending on the interval of the postponed surgery; through study completion, an average of 1 year

• general health status

  depending on the interval of the postponed surgery; through study completion, an average of 1 year

Study Arms (1)

patients with postponed surgery

patients with postponed surgery

Other: questionnaire

Interventions

questionnaire 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.

patients with postponed surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- All patients over the age of 18 attending the Department of Urology for an elective surgery

You may not qualify if:

• lack of ability to give consent
• emergency operations

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Urology, Medical University Graz

Graz, 8010, Austria

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Marianne Leitsmann, Ass.-Prof., MD

CONTACT

+43 316 385 81582; marianne.leitsmann@medunigraz.at

Iva Simunovic, MD

CONTACT

+43 316 385 81963; iva.simunovic@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: October 4, 2023
• Study Start: August 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)