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

Primary Purpose

Vesicoureteral Reflux, Nipple Ureteroneocystostomy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Direct Nipple Ureteroneocystostomy Technique
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vesicoureteral Reflux focused on measuring Nipple, Technique, Ureter, Vesicoureteral Reflux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Megaureter.
  • Ligated Ureter during surgery.

Exclusion Criteria:

  • Neurogenic bladder
  • Surgical wound infection

Sites / Locations

  • Erciyes University Medical Faculty, Department of Urology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Direct Nipple Ureteroneocystostomy

Arm Description

Outcomes

Primary Outcome Measures

Inter-IVU image differences and DMSA uptakes
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.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2013
Last Updated
January 30, 2013
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT01780493
Brief Title
The Long Term Follow-Up Results Of The Direct Nipple Ureteroneocystostomy Technique
Official Title
The Long Term Follow-Up Results Of The Direct Nipple Ureteroneocystostomy Technique: A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesicoureteral Reflux, Nipple Ureteroneocystostomy
Keywords
Nipple, Technique, Ureter, Vesicoureteral Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct Nipple Ureteroneocystostomy
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
The Direct Nipple Ureteroneocystostomy Technique
Primary Outcome Measure Information:
Title
Inter-IVU image differences and DMSA uptakes
Description
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.
Time Frame
3 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Megaureter. Ligated Ureter during surgery. Exclusion Criteria: Neurogenic bladder Surgical wound infection
Facility Information:
Facility Name
Erciyes University Medical Faculty, Department of Urology
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

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

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