NCT00637650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 10, 2009

Status Verified

February 1, 2009

Enrollment Period

10 months

First QC Date

March 12, 2008

Last Update Submit

February 9, 2009

Conditions

Urinary Stones

Outcome Measures

Primary Outcomes (1)

  • unplanned medical visits

    30 days

Secondary Outcomes (1)

  • Hospital Admissions, need for pain killers, time to complete recovery

    60 days

Study Arms (2)

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

OTHER

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

Interventions

Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragmentsPROCEDURE
A
Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragmentPROCEDURE
B

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with ureteral stones suitable for endoscopic treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chaim Sheba Medical Center

Tel Litwinsky, Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Urinary Calculi

Interventions

Ureteroscopy

Condition Hierarchy (Ancestors)

UrolithiasisUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 18, 2008

Study Start

June 1, 2007

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

February 10, 2009

Record last verified: 2009-02

Locations

IL(1)