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Treatment of Upper Ureteric Stones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469766
Recruitment Status : Unknown
Verified August 2016 by muhamad muhamad abdallateef, Mansoura University.
Recruitment status was:  Recruiting
First Posted : June 11, 2015
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
muhamad muhamad abdallateef, Mansoura University

Brief Summary:
This study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.

Condition or disease Intervention/treatment Phase
Ureteric Stones Procedure: SWL Procedure: Semirigid URS Procedure: Flexible URS Phase 4

Detailed Description:
This study will be conducted to compare the success and complication rates of Flexible, Semi-rigid URS, and SWL approaches for proximal ureteric stones with size ≤1 cm.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison Between Flexible Ureteroscopy, Semirigid Ureteroscopy and Extracorporeal Shockwaves Lithotripsy (SWL) in The Management of Proximal Ureteric Stones. A Randomized Controlled Trial
Study Start Date : March 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
Active Comparator: Extracorporeal Shockwaves
Patients in this arm will undergo SWL
Procedure: SWL
Patients in this arm will undergo SWL

Active Comparator: Semirigid URS
Patients in this arm will undergo Semirigid Ureteroscopy
Procedure: Semirigid URS
Patients in this arm will undergo semirigid URS

Active Comparator: Flexible URS
Patients in this arm will undergo Flexible Ureteroscopy
Procedure: Flexible URS
Patients in this arm will undergo Flexible URS




Primary Outcome Measures :
  1. Stone free rate [ Time Frame: 3 months ]
    The stone free rate will be evaluated with non-contrast CT


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: 2 weeks ]
    Complications will be classified according to modified Clavien Dindo



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Radio-opaque stones
  • less than or equal 1 cm

Exclusion Criteria:

  • Active UTI
  • Coagulopathy
  • Pregnancy
  • Ureteric stricture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469766


Contacts
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Contact: Muhamad M abdallateef, MD 01009681644 seif_1901@yahoo.com
Contact: Ahmed R EL-Nahas, MD +20502202222 ext 1699 ar_el_nahas@yahoo.com

Locations
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Egypt
Urology and Nephrology Center Recruiting
Mansoura, Dakhlia, Egypt, 35516
Contact: Muhammad M abdallateef, MD    01009681644    seif_1901@yahoo.com   
Contact: Ahmed R EL-Nahas, MD    +20502202222 ext 1699    ar_el_nahas@yahoo.com   
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Ahmed M Shoma, MD Mansoura University
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Responsible Party: muhamad muhamad abdallateef, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02469766    
Other Study ID Numbers: upper ureteric stones
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by muhamad muhamad abdallateef, Mansoura University:
ureteral stones
ureter
ureteroscopy
flexible
SWL
Additional relevant MeSH terms:
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Ureteral Calculi
Ureterolithiasis
Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi