NCT01780493

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

3.9 years

First QC Date

January 22, 2013

Last Update Submit

January 30, 2013

Conditions

Vesicoureteral RefluxNipple Ureteroneocystostomy

Keywords

NippleTechniqueUreterVesicoureteral Reflux

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Direct Nipple Ureteroneocystostomy

OTHER
Procedure: The Direct Nipple Ureteroneocystostomy Technique

Interventions

The Direct Nipple Ureteroneocystostomy TechniquePROCEDURE
Direct Nipple Ureteroneocystostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Megaureter.
  • Ligated Ureter during surgery.

You may not qualify if:

  • Neurogenic bladder
  • Surgical wound infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Medical Faculty, Department of Urology

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vesico-Ureteral Reflux

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 31, 2013

Study Start

March 1, 2004

Primary Completion

February 1, 2008

Study Completion

August 1, 2011

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

TU(1)