Ureteroscopy With and Without Safety Guidewire

This study has been withdrawn prior to enrollment.
(Withdrawn. Not enough time to go through with the study.)
Sponsor:
Information provided by:
Helse-Bergen HF
ClinicalTrials.gov Identifier:
NCT01117688
First received: May 4, 2010
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to investigate the impact of a safety guidewire (SGW) on the results of ureteroscopy for urolithiasis.

Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment of urolithiasis.


Condition Intervention
Urolithiasis
Procedure: Ureteroscopy with and without safety guidewire

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ureteroscopy With and Without Safety Guidewire:. A Prospective, Randomized Study of the Results of Endoscopic Treatment of Urolithiasis.

Further study details as provided by Helse-Bergen HF:

Primary Outcome Measures:
  • Stone free-rate [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital stay [ Time Frame: Up to 1 week after the operation ] [ Designated as safety issue: No ]
  • Complication rate [ Time Frame: Until 3 months after the procedure ] [ Designated as safety issue: Yes ]
  • Operating time [ Time Frame: Up to 1 day after the surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B - without SGW
Ureteroscopy without SGW in place.
Procedure: Ureteroscopy with and without safety guidewire
In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.
Active Comparator: A - with SGW
Ureteroscopy with SGW in place.
Procedure: Ureteroscopy with and without safety guidewire
In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.

Detailed Description:

The use of SGW is generally recommended at any ureteroscopic procedure in order to facilitate the introduction of the endoscope and to secure placement of internal tubes for drainage of urine after the procedure.

However, SGW may be an obstacle to efficient disintegration and retraction of calculi in the narrow ureter.

The intention of this study is to compare the results of endoscopic stone treatment with and without the use of SGW.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with urolithiasis planned for ureterorenoscopic treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117688

Locations
Norway
Helse Bergen HF, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Helse-Bergen HF
Investigators
Principal Investigator: Øyvind Ulvik, MD Helse Bergen HF, Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Øyvind Ulvik, Helse-Bergen HF, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01117688     History of Changes
Other Study ID Numbers: 102.09 (REK) - 3, 21835 (NSD) - 3, 102.09 (REK) - 3
Study First Received: May 4, 2010
Last Updated: June 23, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by Helse-Bergen HF:
Ureteroscopy

Additional relevant MeSH terms:
Urolithiasis
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014