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

Vesicoureteral Reflux Clinical Trial

Official title:

The Long Term Follow-Up Results Of The Direct Nipple Ureteroneocystostomy Technique: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780493
• Other study ID #: 03.04.2007/172
• Status: Completed
• Phase: N/A
• First received: January 22, 2013
• Last updated: January 30, 2013
• Start date: March 2004
• Est. completion date: August 2011

Study information

• Verified date: January 2013
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2011
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Megaureter.

• Ligated Ureter during surgery.

Exclusion Criteria:

• Neurogenic bladder

• Surgical wound infection

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nipple Ureteroneocystostomy
• Vesico-Ureteral Reflux
• Vesicoureteral Reflux

Intervention

Procedure:
• The Direct Nipple Ureteroneocystostomy Technique

Locations

Country	Name	City	State
Turkey	Erciyes University Medical Faculty, Department of Urology	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 month after surgery	Yes