The Effect of the COVID-19 on Patient Preferences and Decision Making for Obstructive Urinary Stone Interventions

NCT ID: NCT04924790

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-08-01

Brief Summary

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In this study, the investigators aim to evaluate the intervention preferences of patients with obstructive urinary stones who are suitable for operation during the COVID-19 pandemic. The secondary aim is to compare and evaluate the preferences compared to the pre-pandemic period and to gain a perspective on how the decision-making process has changed from the patient's point of view. Thus, by trying to understand how the COVID-19 epidemic affects the treatment choice decisions of patients, the investigators aim to determine how the state of anxiety changes these preferences.

Detailed Description

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The transformative impact of the COVID-19 pandemic on healthcare use remains an open question. At the onset of the pandemic, policies to limit transmission were adopted, including stay-at-home decisions, social distancing, and postponing elective surgery. Such policies have contributed to reduced emergency room admissions, increased concern about COVID-19, and hospital systems have had to prioritize emergency intervention.

Obstructive urolithiasis is a clinical condition that usually causes severe flank pain and causes emergency admission. It is still unclear how the epidemic impairs the treatment pathways of the obstructive urolithiasis that contributes to the emergency room visit. Treatment options range from observation and medical expulsive therapy to operative interventions such as extracorporeal shock wave lithotripsy, ureteroscopy and percutaneous nephrolithotomy. Patient preference, stone characteristics and comorbidities are of great importance in decision making. However, since obstructive ureteral stones that cannot be resolved spontaneously can cause irreversible renal parenchymal damage and obstructive pyelonephritis in a short time, the option of operation is always prioritized.

Patient perspectives on how COVID-19 is changing healthcare use and decision-making still remain unclear. In our study, the investigators plan to record patient treatment preferences by explaining in detail how and where treatment options will be applied, success and complication rates for patients diagnosed with obstructive urolithiasis and suitable for intervention in the outpatient clinic. In addition, when evaluating patient preferences, the investigators foresee to determine how the COVID-19 pandemic process has changed compared to before. It is planned that our study will have a patient-centered approach with detailed oral and written information in outpatient clinic conditions.

Conditions

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Urinary Stone Urinary Calculi Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 Urinary Stone

Patients diagnosed with obstructive urinary stones in the COVID-19 period

COVID-19 Pandemic

Intervention Type BEHAVIORAL

Comparison of the intervention preferences of patients diagnosed with obstructive urinary stones in the urology clinic and recommended for intervention during and before COVID-19

PreCOVID-19 Urinary Stone

Patients diagnosed with obstructive urinary stones in the preCOVID-19 period

COVID-19 Pandemic

Intervention Type BEHAVIORAL

Comparison of the intervention preferences of patients diagnosed with obstructive urinary stones in the urology clinic and recommended for intervention during and before COVID-19

Interventions

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COVID-19 Pandemic

Comparison of the intervention preferences of patients diagnosed with obstructive urinary stones in the urology clinic and recommended for intervention during and before COVID-19

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Obstructive Urinary Stone

Exclusion Criteria

* Previous operation for urinary stone
* Presence of bladder stone
* Presence of stent in the ureter
* Previous radiotherapy to the pelvic and abdominal region
* Pregnancy
* Neurological disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ali Kaan Yildiz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Kaan Yildiz

Role: PRINCIPAL_INVESTIGATOR

Ankara Training and Resarch Hospital

Locations

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Ankara Training and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ali Kaan Yildiz

Role: CONTACT

+90 554 773 16 96

Esra Gulen Yildiz

Role: CONTACT

+90 506 877 47 09

Facility Contacts

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Ali Kaan Yildiz

Role: primary

+90 554 773 16 96

References

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Jiang T, Osadchiy V, Weinberger JM, Zheng MH, Owen MH, Leonard SA, Mills JN, Kachroo N, Eleswarapu SV. Impact of the COVID-19 Pandemic on Patient Preferences and Decision Making for Symptomatic Urolithiasis. J Endourol. 2021 Aug;35(8):1250-1256. doi: 10.1089/end.2020.1141. Epub 2021 Mar 4.

Reference Type BACKGROUND
PMID: 33478351 (View on PubMed)

Campi R, Tellini R, Grosso AA, Amparore D, Mari A, Viola L, Cocci A, Polverino P, Checcucci E, Alessio P, Fiori C, Minervini A, Carini M, Porpiglia F, Serni S. Deferring Elective Urologic Surgery During the COVID-19 Pandemic: The Patients' Perspective. Urology. 2021 Jan;147:21-26. doi: 10.1016/j.urology.2020.09.015. Epub 2020 Sep 24.

Reference Type BACKGROUND
PMID: 32979378 (View on PubMed)

Lee EH, Kim SH, Shin JH, Park SB, Chi BH, Hwang JH. Effects on renal outcome of concomitant acute pyelonephritis, acute kidney injury and obstruction duration in obstructive uropathy by urolithiasis: a retrospective cohort study. BMJ Open. 2019 Nov 3;9(11):e030438. doi: 10.1136/bmjopen-2019-030438.

Reference Type BACKGROUND
PMID: 31685503 (View on PubMed)

Other Identifiers

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COVIDUS2021

Identifier Type: -

Identifier Source: org_study_id

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