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Management of Fragments During Ureteroscopy

This study has been completed.
Sponsor:
Information provided by:
The Chaim Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00637650
First received: March 12, 2008
Last updated: February 9, 2009
Last verified: February 2009
History of Changes
  Purpose

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 Intervention
Urinary Stones
 Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments
Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Should we Strive for Absolute "Stone Freedom" While Performing Holmium Laser Lithotripsy for Ureteral Stones? A Randomized Controlled Trial.

Resource links provided by NLM:

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

Further study details as provided by The Chaim Sheba Medical Center:

Primary Outcome Measures:
  • unplanned medical visits [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospital Admissions, need for pain killers, time to complete recovery [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Study Start Date: June 2007
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637650

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

No publications provided

ClinicalTrials.gov Identifier: NCT00637650     History of Changes
Other Study ID Numbers: 4638
Study First Received: March 12, 2008
Last Updated: February 9, 2009
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on May 21, 2013