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The Long Term Follow-Up Results Of The Direct Nipple Ureteroneocystostomy Technique

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: NCT01780493
Recruitment Status : Completed
First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Abdullah Demirtas, TC Erciyes University

Tracking Information
First Submitted Date  ICMJE January 22, 2013
First Posted Date  ICMJE January 31, 2013
Last Update Posted Date January 31, 2013
Study Start Date  ICMJE March 2004
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2013)
Inter-IVU image differences and DMSA uptakes [ Time Frame: 3 month after surgery ]
In cases attending regular follow-ups, preoperative and postoperative 1st year DMSA results and amount of pelvicaliceal dilatation in the IVU of the unit that underwent surgery were compared statistically (by counting the dots falling on the pelvis and calices using stereologic methods which use transparent acetates with 3-mm inter-grid distances. Inter-IVU image differences between IVUs taken at different centers were resolved by using the value found by counting the dots falling on the 4th lumbar vertebra in both films and proportioning the results with each other as the multiplier. Measurable values were expressed as means + standard deviation.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Long Term Follow-Up Results Of The Direct Nipple Ureteroneocystostomy Technique
Official Title  ICMJE The Long Term Follow-Up Results Of The Direct Nipple Ureteroneocystostomy Technique: A Prospective Study
Brief Summary To evaluate the long term follow-up results of the direct nipple ureteroneocystostomy technique.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vesicoureteral Reflux
  • Nipple Ureteroneocystostomy
Intervention  ICMJE Procedure: The Direct Nipple Ureteroneocystostomy Technique
Study Arms  ICMJE Direct Nipple Ureteroneocystostomy
Intervention: Procedure: The Direct Nipple Ureteroneocystostomy Technique
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2013)
19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Megaureter.
  • Ligated Ureter during surgery.

Exclusion Criteria:

  • Neurogenic bladder
  • Surgical wound infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01780493
Other Study ID Numbers  ICMJE 03.04.2007/172
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abdullah Demirtas, TC Erciyes University
Study Sponsor  ICMJE TC Erciyes University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TC Erciyes University
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP