ESWL on Disintegration of Renal Stones

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03939325
Collaborator
(none)
90
12.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: ESWL

Detailed 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

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Different Shock Wave Release Frequencies on Disintegration of Renal Stones in Assuit Urology & Nephrology University Hospital
Anticipated Study Start Date :
May 5, 2019
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
first group

patient who exposed to frequency 60 shock wave per min

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

second group

patient who exposed to frequency 80 shock wave per min

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

third group

patient who exposed to frequency 100 shock wave per min

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

Outcome Measures

Primary Outcome Measures

  1. stone free rate [2 weeks]

    complete disintegration of renal stones or having clinically insignificant gravel smaller than 2 mm

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 %

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Ahmed Mohamed El Taher, M.B.B.CH, Assiut University
ClinicalTrials.gov Identifier:
NCT03939325
Other Study ID Numbers:
  • impact of ESWL in Renal Stones
First Posted:
May 6, 2019
Last Update Posted:
May 6, 2019
Last Verified:
May 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2019