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The purpose of this study is to investigate the effect of different salt concentrations (tonicity) in the coupling fluid used during Extracorporeal Shock Wave Lithotripsy (ESWL). The study compares three types of coupling fluids: hypotonic (degassed water), isotonic (0.9% NaCl), and hypertonic (3% NaCl) solutions. Researchers aim to determine which solution provides the best stone fragmentation success while minimizing procedure-related pain and skin complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypotonic Group | Active Comparator | Patients in this group received extracorporeal shock wave lithotripsy (ESWL) using hypotonic degassed water as the coupling fluid. (n=97) |
|
| Isotonic Group | Experimental | Patients in this group received extracorporeal shock wave lithotripsy (ESWL) using 0.9% NaCl (isotonic) solution as the coupling fluid. (n=99) |
|
| Hypertonic Group | Experimental | Patients in this group received extracorporeal shock wave lithotripsy (ESWL) using 3% NaCl (hypertonic) solution as the coupling fluid. (n=98) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypotonic degassed water coupling | Procedure | Hypotonic degassed water was used as the coupling fluid during the ESWL procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone Fragmentation Success Rate | The percentage of patients achieving successful stone fragmentation, defined as residual fragments smaller than 4 mm. | 2-4 weeks after the ESWL procedure |
| Post-ESWL Pain Scores | Pain intensity assessed using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain. | Immediately after the ESWL procedure |
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Inclusion Criteria:
Patients with kidney stones measuring 5-20 mm.
Patients scheduled for ESWL treatment.
Age 18 and older
Exclusion Criteria:
Pregnancy.
Uncorrected bleeding disorders.
Active urinary tract infection.
Anatomical abnormalities preventing ESWL.
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Murat Bayraktar, MD | University of Health Sciences, Konya City Hospital, Department of Urology, Konya, Turkey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences, Konya City Hospital | Konya | 42020 | Turkey (Türkiye) |
De-identified individual participant data that underlie the results reported in the article, including demographic characteristics (age, sex), stone characteristics (size, location), pain scores (Visual Analog Scale), and stone fragmentation success rates.
The data will be available beginning 6 months and ending 36 months following article publication.
Data will be shared with qualified researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to the corresponding author's email. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D005191 | Family Characteristics |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D015991 | Epidemiologic Measurements |
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| Isotonic (0.9% NaCl) coupling | Procedure | 0.9% NaCl (isotonic) solution was used as the coupling fluid during the ESWL procedure. |
|
| Hypertonic (3% NaCl) coupling | Procedure | 3% NaCl (hypertonic) solution was used as the coupling fluid during the ESWL procedure. |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011634 |
| Public Health |
| D004778 | Environment and Public Health |