Management of Fragments During Ureteroscopy

Sponsor

The Chaim Sheba Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00637650

Collaborator

(none)

Location

Arms

Duration (Months)

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jun 1, 2007

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

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
Other: 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

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

Other: 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

Outcome Measures

Primary Outcome Measures

unplanned medical visits [30 days]

Secondary Outcome Measures

Hospital Admissions, need for pain killers, time to complete recovery [60 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The Chaim Sheba Medical Center	Tel Hashomer	Ramat Gan	Israel	52621

Sponsors and Collaborators

The Chaim Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00637650

Other Study ID Numbers:

4638

First Posted:

Mar 18, 2008

Last Update Posted:

Feb 10, 2009

Last Verified:

Feb 1, 2009

Additional relevant MeSH terms:

Urinary Calculi

Urolithiasis

Study Results

No Results Posted as of Feb 10, 2009