Management of Fragments During Ureteroscopy - Full Text View

Sponsored by:	The Chaim Sheba Medical Center
Information provided by:	The Chaim Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00637650

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

U.S. FDA Resources

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

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
B: Experimental 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, Ramat Gan
The Chaim Sheba Medical Center
Tel Hashomer, Ramat Gan, Israel, 52621

Sponsors and Collaborators

The Chaim Sheba Medical Center

More Information

No publications provided

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

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Ureterolithiasis
Urologic Diseases

Urolithiasis
Ureteral Calculi
Calculi

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis
Calculi

ClinicalTrials.gov processed this record on May 07, 2009