Management of Fragments During Ureteroscopy

Urinary Stones Clinical Trial

Official title:

Should we Strive for Absolute "Stone Freedom" While Performing Holmium Laser Lithotripsy for Ureteral Stones? A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637650
• Other study ID #: 4638
• Status: Completed
• Phase: N/A
• First received: March 12, 2008
• Last updated: February 9, 2009
• Start date: June 2007
• Est. completion date: May 2008

Study information

• Verified date: February 2009
• Source: The Chaim Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Urinary Calculi
• Urinary Stones

Intervention

Procedure:
• Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments

• Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment

Locations

Country	Name	City	State
Israel	The Chaim Sheba Medical Center	Tel Hashomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
The Chaim Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	unplanned medical visits		30 days	Yes
Secondary	Hospital Admissions, need for pain killers, time to complete recovery		60 days	Yes