Vesicoureteral RefluxNCT01780493

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

A study testing The Direct Nipple Ureteroneocystostomy Technique in people with Vesicoureteral Reflux and Nipple Ureteroneocystostomy, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the long term follow-up results of the direct nipple ureteroneocystostomy technique. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vesicoureteral Reflux, Nipple Ureteroneocystostomy
What is being tested?: The Direct Nipple Ureteroneocystostomy Technique
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Mar 2004to Aug 2011
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Megaureter.
Ligated Ureter during surgery.

Who cannot join

Neurogenic bladder
Surgical wound infection

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Erciyes University Medical Faculty, Department of Urology
Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

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

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

Conditions: Vesicoureteral Reflux, Nipple Ureteroneocystostomy
Being tested: The Direct Nipple Ureteroneocystostomy Technique
Keywords: Nipple, Technique, Ureter, Vesicoureteral Reflux
Medical subject headings: Vesico-Ureteral Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Direct Nipple Ureteroneocystostomy TechniqueProcedure or surgery

Study groups in NCT01780493
Study group	Role	What they receive
Direct Nipple Ureteroneocystostomy	Other	Not described Receives: Procedure: The Direct Nipple Ureteroneocystostomy Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Aug 2011

First posted31 Jan 2013 (estimated)
Study startMar 2004
Primary completionFeb 2008
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Vesicoureteral RefluxStudies of the same condition, open and under way.
More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01780493
Sponsor's protocol ID: 03.04.2007/172
Status last verified: Jan 2013
First submitted: 22 Jan 2013
Last updated: 31 Jan 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
Vesico-Ureteral Reflux
RecruitingObservational study
Study of Gut Microbiota Diversity in Children Aged 1-3 Years on Prolonged Antibiotic Prophylaxis for Grade 3 or Higher Vesicoureteral Reflux Compared With 2 Age-matched Control Groups
Vesicoureteral Reflux 3
RecruitingPhase 3
Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter
Not yet recruiting
Diagnostic Performance of PIC Cystogram vs VCUG in Children
Pediatric Urology
Recruiting
Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
VUR - Vesicoureteric Reflux

All Vesicoureteral Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Long Term Follow-Up Results Of The Direct Nipple Ureteroneocystostomy Technique: A Prospective Study
ClinicalTrials.gov ID: NCT01780493
Acronym / sponsor ID: 03.04.2007/172
Conditions: Vesicoureteral Reflux, Nipple Ureteroneocystostomy
Keywords: Nipple, Technique, Ureter, Vesicoureteral Reflux
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: TC Erciyes UniversityUniversity, hospital or other
Study start: Mar 2004
Primary completion: Feb 2008 (actual)
Study completion: Aug 2011 (actual)
First posted: 31 Jan 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Direct Nipple Ureteroneocystostomy	Other	Procedure: The Direct Nipple Ureteroneocystostomy Technique

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Megaureter.
Ligated Ureter during surgery.

Key exclusion criteria (2 listed)

Neurogenic bladder
Surgical wound infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The Direct Nipple Ureteroneocystostomy Technique	Procedure or surgery	Direct Nipple Ureteroneocystostomy

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.

Related trials for Vesicoureteral Reflux

Not yet recruitingPhase 1
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
Vesico-Ureteral Reflux
RecruitingObservational study
Study of Gut Microbiota Diversity in Children Aged 1-3 Years on Prolonged Antibiotic Prophylaxis for Grade 3 or Higher Vesicoureteral Reflux Compared With 2 Age-matched Control Groups
Vesicoureteral Reflux 3
RecruitingPhase 3
Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter
Not yet recruiting
Diagnostic Performance of PIC Cystogram vs VCUG in Children
Pediatric Urology
Recruiting
Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
VUR - Vesicoureteric Reflux

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The Direct Nipple Ureteroneocystostomy Technique in people with Vesicoureteral Reflux and Nipple Ureteroneocystostomy, run by TC Erciyes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inter-IVU image differences and DMSA uptakes (time frame: 3 month after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01780493.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.