A Prospective Randomized Controlled Clinical Trial of the Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate

Lawson Health Research Institute5 sites in 1 country44 target enrollmentMay 2005

ConditionsUrinary Calculi

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Urinary Calculi
Sponsor: Lawson Health Research Institute
Enrollment: 44
Locations: 5
Primary Endpoint: The primary end point is the stone free rate at 3 months post ureteroscopy.
Status: Terminated
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Patients with upper ureteral or renal stones will be randomized to undergoing ureteroscopy with or without a ureteral access sheath. The sheath is designed to facilitate ureteroscope insertion and re-insertion, thus allowing fragments to be basketed out. Stone free rates at 3 months will be determined between the two groups.

The investigators hypothesize that the use of the ureteral access sheath with ureteroscopy will result in improved stone free rates at 3 months compared to ureteroscopy without use of a sheath.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

May 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lawson Health Research Institute

Eligibility Criteria

Inclusion Criteria

•Upper ureteral (proximal to iliac vessels/iliac crest) calculi;
•Renal calculi;
•Normal renal function;
•Any stone composition;
•Single or multiple stones(planned treatment of all stones at this surgery);
•Age \> 18 years;
•Able and willing to return treatment centre for follow-up visits; AND
•Signed study consent

Exclusion Criteria

•Ureteric calculi distal to the level of the iliac vessels/iliac crest;
•Failed ureteroscopy for same stone (i.e. has to be the first ureteroscopic procedure for this stone, however a prior failed extracorporeal shockwave lithotripsy (SWL) is acceptable);
•Bilateral ureteroscopy;
•If an adjunctive procedure is planned post ureteroscopy (e.g. percutaneous nephrolithotomy, SWL) (i.e. it is known preoperatively that a ureteroscopic procedure will not render the patient stone free and that ancillary procedures will be necessary);
•If in the investigators opinion, enrollment would be not be appropriate; OR
•Pregnancy

Outcomes

Primary Outcomes

The primary end point is the stone free rate at 3 months post ureteroscopy.

Time Frame: 3 months post ureteroscopy

Secondary Outcomes

Secondary end points include operative and surgical factors such as operative time, stone size, stone location, stone composition, patient sex and the presence of a ureteric stent post-op.(at time of intervention)