Management of Fragments During Ureteroscopy - Tabular View

Tracking Information
First Received Date ^ICMJE	March 12, 2008
Last Updated Date	February 9, 2009
Start Date ^ICMJE	June 2007
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 9, 2009)	unplanned medical visits [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: March 12, 2008)	need for re-intervention [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00637650 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 9, 2009)	Hospital Admissions, need for pain killers, time to complete recovery [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 12, 2008)	Hospital Admissions, Visit to ER, need for pain killers [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Descriptive Information
Brief Title ^ICMJE	Management of Fragments During Ureteroscopy
Official Title ^ICMJE	Should we Strive for Absolute "Stone Freedom" While Performing Holmium Laser Lithotripsy for Ureteral Stones? A Randomized Controlled Trial.
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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Randomized, Open Label, Active Control, Parallel Assignment
Condition ^ICMJE	Urinary Stones
Intervention ^ICMJE	Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment
Study Arms / Comparison Groups	Experimental: Experimental group: patients in whom "stone dust" was left for spontaneous elimination Other: Control group: Patients in whom all fragments resulting from laser lithotripsy of ureteral stones were actively retrieved
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	May 2008
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT ID ^ICMJE	NCT00637650
Responsible Party
Study ID Numbers ^ICMJE	4638
Study Sponsor ^ICMJE	The Chaim Sheba Medical Center
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	The Chaim Sheba Medical Center
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP