Uretro-pelvic Junction ObstructionNCT05953571
Laparoscopic Assisted Dismembered Pyeloplasty Versus Open Pyeloplasty in (UPJO) With Poorly Function Kidney in Pediatrics
An observational study of Uretro-pelvic Junction Obstruction and Poorly Function Kidney, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The management of kidneys with poor function less than 10% has been the subject of debate for more than a decade. Some authors have recommended nephrectomy while others favor renal salvage (pyeloplasty). Read more about this study
- Who is it for?
- Ages 2 months to 14 years
- Conditions the study is for
- Uretro-pelvic Junction Obstruction, Poorly Function Kidney
- What is being tested?
- Dismembered Pyeloplasty
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jan 2022to 30 Jun 2023
- Phase
- Observational
- 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 2 months to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children suffered from Uretro-pelvic junction obstruction with split renal function less than 10%
Who may be able to join
- Patients with hydronephrosis diagnosed as UPJO
- Antero-Posterior pelvic diameter more than 20 mm
- renal function equal or less than 10%,
- corrected by laparoscopic assisted or open pyeloplasty
Who cannot join
- Patients with ureteral dilatation (VUR),
- renal function more than 10%,
- acquired and recurrent cases
Trial locations and contacts
1 site in 1 country.
About this study
The management of kidneys with poor function less than 10% has been the subject of debate for more than a decade. Some authors have recommended nephrectomy while others favor renal salvage (pyeloplasty). the investigators reported their experience of lap assisted pyeloplasty in poorly functioning kidneys in the pediatric age group, concerning on the benefits of a minimally invasive method for repair of UPJO, in comparison with open approach.
- Being tested
- Dismembered Pyeloplasty
- Keywords
- UPJO, Poorly function kidney, Laparoscopic assissted pyeloplasty, Open pyeloplasty, Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dismembered PyeloplastyProcedure or surgery
dismembered Anderson-Hynes repair was performed using 5/0 absorbable suture.
| Study group | Role | What they receive |
|---|---|---|
| GroupA | Laparoscopic assisted dismembered pyeloplasty in poorly function kidney Receives: Procedure: Dismembered Pyeloplasty | |
| Group B | Open dismembered pyeloplasty in poorly function kidney Receives: Procedure: Dismembered Pyeloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Split renal function by Renal scan (DTPA) %
Measured: 12 months post-operative
Measurments A-P renal pelvis diameter
ultrasound measuerment of renal pelvis diameter by mm
Measured: 12 months
Secondary outcomes (1)
operative time
operative time by minutes
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start8 Jan 2022
- Primary completion8 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uretro-pelvic Junction ObstructionStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Fattouma Bourguiba
- Responsible party
- Principal investigator, Mohammad Daboos, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953571
- Sponsor's protocol ID
- 8-1-2022-000048
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Assisted Dismembered Pyeloplasty Versus Open Pyeloplasty in (UPJO) With Poorly Function Kidney in Pediatrics
- ClinicalTrials.gov ID
- NCT05953571
- Acronym / sponsor ID
- 8-1-2022-000048
- Keywords
- UPJO, Poorly function kidney, Laparoscopic assissted pyeloplasty, Open pyeloplasty, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- University Hospital Fattouma Bourguiba
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Jul 2023 (actual)
- 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.
The management of kidneys with poor function less than 10% has been the subject of debate for more than a decade. Some authors have recommended nephrectomy while others favor renal salvage (pyeloplasty). the investigators reported their experience of lap assisted pyeloplasty in poorly functioning kidneys in the pediatric age group, concerning on the benefits of a minimally invasive method for repair of UPJO, in comparison with open approach.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GroupA | – | Procedure: Dismembered PyeloplastyLaparoscopic assisted dismembered pyeloplasty in poorly function kidney |
| Group B | – | Procedure: Dismembered PyeloplastyOpen dismembered pyeloplasty in poorly function kidney |
Who may qualify
- Ages
- 2 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children suffered from Uretro-pelvic junction obstruction with split renal function less than 10%
Key inclusion criteria (4 listed)
- Patients with hydronephrosis diagnosed as UPJO
- Antero-Posterior pelvic diameter more than 20 mm
- renal function equal or less than 10%,
- corrected by laparoscopic assisted or open pyeloplasty
Key exclusion criteria (3 listed)
- Patients with ureteral dilatation (VUR),
- renal function more than 10%,
- acquired and recurrent cases
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 |
|---|---|---|
| Dismembered Pyeloplastydismembered Anderson-Hynes repair was performed using 5/0 absorbable suture. | Procedure or surgery | Group B, GroupA |
Primary outcome
Renal function
Time frame: 12 months post-operative
Split renal function by Renal scan (DTPA) %
Measurments A-P renal pelvis diameter
Time frame: 12 months
ultrasound measuerment of renal pelvis diameter by mm
1 secondary outcome
operative time
Time frame: one month
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 Jul 2023.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Uretro-pelvic Junction Obstruction and Poorly Function Kidney, run by Al-Azhar 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 4 inclusion and 3 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 Jul 2023. 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?
Renal function (time frame: 12 months post-operative). The study lists 2 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 Jul 2023.