Adjunct Inversion for Lower Pole Stone

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2008-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Kidney Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Inversion, Hydration, ESWL

ESWL with hydration and inversion

Group Type EXPERIMENTAL

Inversion

Intervention Type PROCEDURE

Patients inverted 30 degree head down in Trendelenburg position

Shock Wave Lithotripsy

Intervention Type PROCEDURE

Shock wave lithotripsy

Hydration

Intervention Type DRUG

Hydration of patient with 0.5L NaCl and 20mg frusemide IV

ESWL, Hydration

ESWL with hydration

Group Type ACTIVE_COMPARATOR

Shock Wave Lithotripsy

Intervention Type PROCEDURE

Shock wave lithotripsy

Hydration

Intervention Type DRUG

Hydration of patient with 0.5L NaCl and 20mg frusemide IV

Interventions

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Inversion

Patients inverted 30 degree head down in Trendelenburg position

Intervention Type PROCEDURE

Shock Wave Lithotripsy

Shock wave lithotripsy

Intervention Type PROCEDURE

Hydration

Hydration of patient with 0.5L NaCl and 20mg frusemide IV

Intervention Type DRUG

Other Intervention Names

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ESWL Frusemide 20mg

Eligibility Criteria

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Inclusion Criteria

1. Solitary lower pole caliceal stone which is \> 5 mm and \< 20mm
2. Not contraindicated for intravenous urogram (IVU) and subsequent X-rays
3. Patient able to comply strictly with visits/medications
4. Patient willing and agrees to enter study

Exclusion Criteria

1. Impaired function of the affected kidney
2. Gross hydronephrosis of the affected kidney
3. Associated distal obstruction
4. Multiple stones
5. Stone more than 2 cm in size
6. Diverticular stone
7. Patients who are contraindicated for extracorporeal shockwave lithotripsy e.g.: Pregnancy
8. Patients who are unable to tolerate the procedure
9. Significant cardiac condition that does not allow the administration of force hydration or inversion.
10. Uncontrolled hypertension

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No