Pelviureteric Junction ObstructionNCT02138877
Dismembered Pyeloplasty With and Without After Coming Stent
A study testing After coming stent after dismembered pyeloplasty and Stentless dismembered pyeloplasty in people with Pelviureteric Junction Obstruction and Pyeloplasty, run by Cairo University at 1 site in Egypt.
Trial summary
to compare outcome of pyeloplasty in pediatric population less than 6 months in age using an after coming stent versus stentless pyeloplasty. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Pelviureteric Junction Obstruction, Pyeloplasty, Neonatal Hydronephrosis
- What is being tested?
- After coming stent after dismembered pyeloplasty and Stentless dismembered pyeloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2014to Jun 2015
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pelvi-ureteric junction obstruction (PUJO)
- Asymptomatic obstruction with reduced function (less than 35-40%)
- Asymptomatic obstruction with antero-posterior diameter exceed 40 mm
- Asymptomatic obstruction with deterioration on conservative follow up.
- Symptomatic PUJ obstruction, e.g. pain, renal mass, fever and stones.
Who cannot join
- Secondary Pelvi-ureteric junction obstruction
- Solitary kidney
- Gross pyuria
- Ectopic kidney
- Dilated ureter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dismembered Pyeloplasty With and Without After Coming Stent in Neonatal Ureteropelvic Junction Obstruction
to compare outcome of pyeloplasty in pediatric population less than 6 months in age using an after coming stent versus stentless pyeloplasty.
Read the detailed description
A prospective randomized control study including patients divided into two groups,all patient undergoes dismembered pyeloplasty First group will be with an after coming stent ,Second group will be stentless to compare outcome of pyeloplasty in pediatric population less than 6 months in age
- Conditions
- Pelviureteric Junction Obstruction, Pyeloplasty, Neonatal Hydronephrosis, Obstructive Uropathy, Urinary Stent
- Being tested
- After coming stent after dismembered pyeloplasty, Stentless dismembered pyeloplasty
- Keywords
- Pelviureteric junction obstruction, pyeloplasty, Neonate affected by hydronephrosis, obstructive uropathy, urinary stent
- Medical subject headings
- Multicystic renal dysplasia, bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After coming stent after dismembered pyeloplastyProcedure or surgery
Dismembered pyeloplasty through lumbar incision. The patients who are randomized to the after coming stent arm, an after coming stent is inserted. Distal part of it is positioned in the mid ureter. The proximal end is passed through the renal parenchyma (usually the lower kidney calyx) to be exteriorized through stab wound and fixed to the skin. The size of external stent is 4-5 F.
Stentless dismembered pyeloplastyProcedure or surgery
Dismembered pyeloplasty through lumbar incision. No stents are inserted
| Study group | Role | What they receive |
|---|---|---|
| After coming stent | Active comparator | Dismembered pyeloplasty with insertion of an after coming stent Receives: Procedure: After coming stent after dismembered pyeloplasty |
| Stentless | Active comparator | Stentless dismembered pyeloplasty Receives: Procedure: Stentless dismembered pyeloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Hospital stay
Postoperative Hospital stay
Measured: 1 week
Leakage
occurrence of post operative leakage
Measured: 1 week
2ry intervention
Need for 2ry intervention in the form of insertion of ureteral stent
Measured: 1 month
Fever
Postoperative fever
Measured: 1 month
Secondary outcomes (2)
Assessment of kidney function after repair
- Assessment of kidney function after repair using renogram and ultrasound
Measured: 6 months
success
Need for 2ry treatment of persistent pelviureteric junction obstruction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelviureteric Junction ObstructionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed said elsheemy, Cairo University
- Investigators
- Mohammed S ElSheemy, A professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138877
- Sponsor's protocol ID
- 61178
- Status last verified
- Jan 2016
- First submitted
- 10 May 2014
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dismembered Pyeloplasty With and Without After Coming Stent in Neonatal Ureteropelvic Junction Obstruction
- ClinicalTrials.gov ID
- NCT02138877
- Acronym / sponsor ID
- 61178
- Conditions
- Pelviureteric Junction Obstruction, Pyeloplasty, Neonatal Hydronephrosis, Obstructive Uropathy, Urinary Stent
- Keywords
- Pelviureteric junction obstruction, pyeloplasty, Neonate affected by hydronephrosis, obstructive uropathy, urinary stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 May 2014 (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 compare outcome of pyeloplasty in pediatric population less than 6 months in age using an after coming stent versus stentless pyeloplasty.
Detailed description
A prospective randomized control study including patients divided into two groups,all patient undergoes dismembered pyeloplasty First group will be with an after coming stent ,Second group will be stentless to compare outcome of pyeloplasty in pediatric population less than 6 months in age
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| After coming stent | Active comparator | Procedure: After coming stent after dismembered pyeloplastyDismembered pyeloplasty with insertion of an after coming stent |
| Stentless | Active comparator | Procedure: Stentless dismembered pyeloplastyStentless dismembered pyeloplasty |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Pelvi-ureteric junction obstruction (PUJO)
- Asymptomatic obstruction with reduced function (less than 35-40%)
- Asymptomatic obstruction with antero-posterior diameter exceed 40 mm
- Asymptomatic obstruction with deterioration on conservative follow up.
- Symptomatic PUJ obstruction, e.g. pain, renal mass, fever and stones.
Key exclusion criteria (5 listed)
- Secondary Pelvi-ureteric junction obstruction
- Solitary kidney
- Gross pyuria
- Ectopic kidney
- Dilated ureter
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 |
|---|---|---|
| After coming stent after dismembered pyeloplastyDismembered pyeloplasty through lumbar incision. The patients who are randomized to the after coming stent arm, an after coming stent is inserted. Distal part of it is positioned in the mid ureter. The proximal end is passed through the renal parenchyma (usually the lower kidney calyx) to be exteriorized through stab wound and fixed to the skin. The size of external stent is 4-5 F. | Procedure or surgery | After coming stent |
| Stentless dismembered pyeloplastyDismembered pyeloplasty through lumbar incision. No stents are inserted | Procedure or surgery | Stentless |
Primary outcome
Postoperative Hospital stay
Time frame: 1 week
Postoperative Hospital stay
Leakage
Time frame: 1 week
occurrence of post operative leakage
2ry intervention
Time frame: 1 month
Need for 2ry intervention in the form of insertion of ureteral stent
Fever
Time frame: 1 month
Postoperative fever
2 secondary outcomes
Assessment of kidney function after repair
Time frame: 6 months
success
Time frame: 6 months
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 20 Jan 2016.
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Ultrasound Localization Microscopy in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)
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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.
Mohammed S ElSheemy, A professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing After coming stent after dismembered pyeloplasty and Stentless dismembered pyeloplasty in people with Pelviureteric Junction Obstruction and Pyeloplasty, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 5 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 20 Jan 2016. 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 Egypt. 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?
Postoperative Hospital stay (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2016.