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| Name | Class |
|---|---|
| Lam Wah Ee Hospital | OTHER |
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This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inversion, Hydration, ESWL | Experimental | ESWL with hydration and inversion |
|
| ESWL, Hydration | Active Comparator | ESWL with hydration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inversion | Procedure | Patients inverted 30 degree head down in Trendelenburg position |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Are Stone Free at 3 Months | To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liong Men Long, MBBS | Lam Wah Ee Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24044912 | Derived | Leong WS, Liong ML, Liong YV, Wu DB, Lee SW. Does simultaneous inversion during extracorporeal shock wave lithotripsy improve stone clearance: a long-term, prospective, single-blind, randomized controlled study. Urology. 2014 Jan;83(1):40-4. doi: 10.1016/j.urology.2013.08.004. Epub 2013 Sep 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inversion, Hydration, ESWL | ESWL with hydration and inversion Inversion: Patients inverted 30 degree head down in Trendelenburg position Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV |
| FG001 | ESWL, Hydration | ESWL with hydration Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inversion, Hydration, ESWL | ESWL with hydration and inversion Inversion: Patients inverted 30 degree head down in Trendelenburg position Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV |
| BG001 | ESWL, Hydration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Are Stone Free at 3 Months | To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR) | Posted | Number | participants | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inversion, Hydration, ESWL | ESWL with hydration and inversion Inversion: Patients inverted 30 degree head down in Trendelenburg position Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Shaun Lee | Monash University | 55145890 | shaun.lee@monash.edu |
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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 |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Shock Wave Lithotripsy | Procedure | Shock wave lithotripsy |
|
|
| Hydration | Drug | Hydration of patient with 0.5L NaCl and 20mg frusemide IV |
|
|
ESWL with hydration Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 71 |
| 1 |
| 71 |
| EG001 | ESWL, Hydration | ESWL with hydration Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV | 0 | 68 | 2 | 68 |
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| 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 |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |