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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abdullah Demirtas, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT01780493
First received: January 22, 2013
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

To evaluate the long term follow-up results of the direct nipple ureteroneocystostomy technique.


Condition Intervention
Vesicoureteral Reflux
Nipple Ureteroneocystostomy
 Procedure: The Direct Nipple Ureteroneocystostomy Technique

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Long Term Follow-Up Results Of The Direct Nipple Ureteroneocystostomy Technique: A Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by TC Erciyes University:

Primary Outcome Measures:
  • Inter-IVU image differences and DMSA uptakes [ Time Frame: 3 month after surgery ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 19
Study Start Date: March 2004
Study Completion Date: August 2011
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Direct Nipple Ureteroneocystostomy Procedure: The Direct Nipple Ureteroneocystostomy Technique

  Eligibility

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

Inclusion Criteria:

  • Megaureter.
  • Ligated Ureter during surgery.

Exclusion Criteria:

  • Neurogenic bladder
  • Surgical wound infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780493

Locations
Turkey
Erciyes University Medical Faculty, Department of Urology
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
  More Information

No publications provided

Responsible Party: Abdullah Demirtas, Assistant Professor, TC Erciyes University
ClinicalTrials.gov Identifier: NCT01780493     History of Changes
Other Study ID Numbers: 03.04.2007/172
Study First Received: January 22, 2013
Last Updated: January 30, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by TC Erciyes University:
Nipple
Technique
Ureter
Vesicoureteral Reflux

Additional relevant MeSH terms:
Vesico-Ureteral Reflux
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013