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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03939325
Other study ID # impact of ESWL in Renal Stones
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 5, 2019
Est. completion date June 2020

Study information

Verified date May 2019
Source Assiut University
Contact Mohamed A EL Taher
Phone 01127204629
Email mohamed_el_taher7392@yahoo.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The impact of different frequencies on pattern of disintegration of renal stones


Description:

- Prior to the introduction of extracorporeal shockwave lithotripsy (ESWL) in 1980, the only treatment available for calculi that could not pass through the urinary tract was open surgery. Since then, ESWL has become the preferred tool in the urologist's armamentarium for the treatment of renal stones, , ESWL is minimally invasive, exposes patients to less anaesthesia, and yields equivalent stone-free rates in appropriately selected patients.

- The efficacy of ESWL lies in its ability to pulverize calculi in vivo into smaller fragments, which the body can then expulse spontaneously. Shockwaves are generated and then focused onto a point within the body. The shockwaves propagate through the body with negligible dissipation of energy (and therefore damage) owing to the minimal difference in density of the soft tissues. At the stone-fluid interface, the relatively large difference in density, coupled with the concentration of multiple shockwaves in a small area, produces a large dissipation of energy. Via various mechanisms, this energy is then able to overcome the tensile strength of the calculi, leading to fragmentation. Repetition of this process eventually leads to pulverization of the calculi into small fragments that the body can pass spontaneously and painlessly.

- It is well recognized that the popularity of extracorporeal shock wave lithotripsy (SWL), despite its non-invasive character, has decreased during recent years. This is partly explained by the technological achievements in endoscopy and urologists' enthusiasm for such procedures. Another explanation is that many urologists have been insufficiently successful with SWL. The latter effect might to some extent be a result of the performance of the lithotripter used, but in too many cases, it is evident that the principles of how shock wave lithotripsy should be carried out are poorly appliedical aspect


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Pelvic and upper ureteric stones

- Stone size less than 2 cm

- Stone density up to 1000 HU

Exclusion Criteria:

- Lower calycle stone

- Stone size 2 cm or more

- Stone denstiy more than 1000

- age group less than 18 y

- uncontrolled hypertension patient and bleeding disorder

- Pregnancy

- Patients with UPJ obstruction, ureteral strictures,

- Congenital anomalies

- Previous stented ureter

- Narrow neck of the calycx less than 30 %

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
ESWL
The impact of different frequencies on pattern of disintegration of renal stones

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

McClinton S, Cameron S, Starr K, Thomas R, MacLennan G, McDonald A, Lam T, N'Dow J, Kilonzo M, Pickard R, Anson K, Keeley F, Burgess N, Clark CT, MacLennan S, Norrie J; TISU Study Group. TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial. Trials. 2018 May 22;19(1):286. doi: 10.1186/s13063-018-2652-1. — View Citation

Shinde S, Al Balushi Y, Hossny M, Jose S, Al Busaidy S. Factors Affecting the Outcome of Extracorporeal Shockwave Lithotripsy in Urinary Stone Treatment. Oman Med J. 2018 May;33(3):209-217. doi: 10.5001/omj.2018.39. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary stone free rate complete disintegration of renal stones or having clinically insignificant gravel smaller than 2 mm 2 weeks
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