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Management of Fragments During Ureteroscopy

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ClinicalTrials.gov Identifier: NCT00637650
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : February 10, 2009
Sponsor:
Information provided by:
The Chaim Sheba Medical Center

Brief Summary:
The purpose of this study is to study the outcome of patients after ureteroscopy in which all fragments remaining after holmium laser lithotripsy were retrieved compared to those where small, insignificant fragments were left for spontaneous passage.

Condition or disease Intervention/treatment Phase
Urinary Stones Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Should we Strive for Absolute "Stone Freedom" While Performing Holmium Laser Lithotripsy for Ureteral Stones? A Randomized Controlled Trial.
Study Start Date : June 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Holmium
U.S. FDA Resources

Arm Intervention/treatment
Experimental: B
Experimental group: patients in whom "stone dust" was left for spontaneous elimination
Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment
A
Control group: Patients in whom all fragments resulting from laser lithotripsy of ureteral stones were actively retrieved
Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments



Primary Outcome Measures :
  1. unplanned medical visits [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Hospital Admissions, need for pain killers, time to complete recovery [ Time Frame: 60 days ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with ureteral stones suitable for endoscopic treatment

Exclusion Criteria:

  • presence of ipsilateral kidney stones
  • known ureteral stricture
  • previous placement of ureteral stent
  • use of drugs with known activity on smooth ureteral muscle
  • unwillingness or impossibility to return for follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637650


Locations
Israel
The Chaim Sheba Medical Center
Tel Hashomer, Ramat Gan, Israel, 52621
Sponsors and Collaborators
The Chaim Sheba Medical Center

ClinicalTrials.gov Identifier: NCT00637650     History of Changes
Other Study ID Numbers: 4638
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: February 10, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Urinary Calculi
Urolithiasis
Urologic Diseases
Calculi
Pathological Conditions, Anatomical