Pelvi-ureteric Junction ObstructionNCT06822270
Different Surgical Modalities in the Management of Pelvi-ureteric Junction Obstruction
A study testing open surgery and Laparoscopic Pyeloplasty in people with Pelvi-ureteric Junction Obstruction, run by Assiut University at 1 site in Egypt.
Trial summary
The study compared open pyeloplasty (OP) and laparoscopic pyeloplasty (LP) for treating Pelvi-ureteric Junction Obstruction (PUJO) in 40 patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pelvi-ureteric Junction Obstruction
- What is being tested?
- open surgery and Laparoscopic Pyeloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Oct 2024to 4 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 7 months and 60 years. Diagnosed with Pelvi-ureteric Junction Obstruction (PUJO). Glomerular Filtration Rate (GFR) greater than 10 ml/min. Open to both genders.
Who cannot join
- Active infection. GFR less than 10 ml/min. Presence of a single kidney. Patients with kidney or multiple congenital anomalies. Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different Surgical Modalities in the Management of Pelvi-ureteric Junction Obstruction: A Randomized Controlled Trial
The study compared open pyeloplasty (OP) and laparoscopic pyeloplasty (LP) for treating Pelvi-ureteric Junction Obstruction (PUJO) in 40 patients.
- Conditions
- Pelvi-ureteric Junction Obstruction
- Being tested
- open surgery, Laparoscopic Pyeloplasty
- 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.
open surgeryProcedure or surgery
open surgical methods for treating Pelvi-ureteric Junction Obstruction
Laparoscopic PyeloplastyProcedure or surgery
minimally invasive laparoscopic techniques.
| Study group | Role | What they receive |
|---|---|---|
| Open Pyeloplasty Group | Active comparator | This group underwent traditional open surgical methods for treating Pelvi-ureteric Junction Obstruction. Receives: Procedure: open surgery |
| Laparoscopic Pyeloplasty Group (LP) | Experimental | This group was treated using minimally invasive laparoscopic techniques. Receives: Procedure: Laparoscopic Pyeloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Success Rate
evaluating the effectiveness of each surgical method in resolving PUJO
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start11 Oct 2024
- Primary completion11 Oct 2024
- Study completion4 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvi-ureteric Junction ObstructionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamil Ahmed Saleh, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822270
- Sponsor's protocol ID
- MD/AZ.AST/AIP029/21/186/3/2018
- Status last verified
- Feb 2025
- First submitted
- 28 Dec 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD) might not be shared due to privacy and confidentiality concerns. The ethical considerations mentioned in the study include informed consent obtained from patients regarding the surgery and data privacy. Sharing IPD could potentially compromise patient anonymity and expose sensitive personal health information, which must be protected under ethical research practices and relevant data protection regulations.
Publications
Bar-Sever Z, Shammas A, Gheisari F, Vali R. Pediatric Nephro-Urology: Overview and Updates in Diuretic Renal Scans and Renal Cortical Scintigraphy. Semin Nucl Med. 2022 Jul;52(4):419-431. doi: 10.1053/j.semnuclmed.2021.12.002. Epub 2022 Jan 11.
PubMed 35031115
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Surgical Modalities in the Management of Pelvi-ureteric Junction Obstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06822270
- Acronym / sponsor ID
- MD/AZ.AST/AIP029/21/186/3/2018
- Conditions
- Pelvi-ureteric Junction Obstruction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 4 Dec 2025 (estimated)
- First posted
- 12 Feb 2025 (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 study compared open pyeloplasty (OP) and laparoscopic pyeloplasty (LP) for treating Pelvi-ureteric Junction Obstruction (PUJO) in 40 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Pyeloplasty Group | Active comparator | Procedure: open surgeryThis group underwent traditional open surgical methods for treating Pelvi-ureteric Junction Obstruction. |
| Laparoscopic Pyeloplasty Group (LP) | Experimental | Procedure: Laparoscopic PyeloplastyThis group was treated using minimally invasive laparoscopic techniques. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 7 months and 60 years. Diagnosed with Pelvi-ureteric Junction Obstruction (PUJO). Glomerular Filtration Rate (GFR) greater than 10 ml/min. Open to both genders.
Key exclusion criteria (1 listed)
- Active infection. GFR less than 10 ml/min. Presence of a single kidney. Patients with kidney or multiple congenital anomalies. Pregnancy.
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 |
|---|---|---|
| open surgeryopen surgical methods for treating Pelvi-ureteric Junction Obstruction | Procedure or surgery | Open Pyeloplasty Group |
| Laparoscopic Pyeloplastyminimally invasive laparoscopic techniques. | Procedure or surgery | Laparoscopic Pyeloplasty Group (LP) |
Primary outcome
Operative Success Rate
Time frame: 3 days
evaluating the effectiveness of each surgical method in resolving PUJO
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Results publication: PubMed 35031115Bar-Sever Z, Shammas A, Gheisari F, Vali R. Pediatric Nephro-Urology: Overview and Updates in Diuretic Renal Scans and Renal Cortical Scintigraphy. Semin Nucl Med. 2022 Jul;52(4):419-431. doi: 10.1053/j.semnuclmed.2021.12.002. Epub 2022 Jan 11.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD) might not be shared due to privacy and confidentiality concerns. The ethical considerations mentioned in the study include informed consent obtained from patients regarding the surgery and data privacy. Sharing IPD could potentially compromise patient anonymity and expose sensitive personal health information, which must be protected under ethical research practices and relevant data protection regulations.
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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.
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 open surgery and Laparoscopic Pyeloplasty in people with Pelvi-ureteric Junction Obstruction, run by Assiut 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Operative Success Rate (time frame: 3 days). 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 NCT06822270, which also lists 1 linked publication.
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 12 Feb 2025.