Urologic DiseasesNCT05748964
Different Surgical Approaches for Treatment of UPJ Obstruction in Children: Prospective Randomized Clinical Trial
An observational study of Urologic Diseases and Surgery, run by Assiut University.
Trial summary
This study aimed to evaluate the clinical efficacy of laparoscopic pyeloplasty (LP) for ureteropelvic junction obstruction (UPJO) via retroperitoneal and transperitoneal approaches. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Urologic Diseases, Surgery
- What is being tested?
- Laparoscopic pyeloplasty
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Jun 2025
- How long will I take part?
- 1 Year
- 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 to 18 years
- All sexes
- Child, Adult
Study population: Children diagnosed with unilateral ureteropelvic junction obstruction
Who may be able to join
- Age above two years.
- Unilateral UPJO.
Who cannot join
- Age below two years.
- Bilateral UPJO.
- Recurrent UPJO.
- Malrotated kidneys and renal fusion anomalies.
About this study
This study aimed to evaluate the clinical efficacy of laparoscopic pyeloplasty (LP) for ureteropelvic junction obstruction (UPJO) via retroperitoneal and transperitoneal approaches.
Read the detailed description
Ureteropelvic junction obstruction (UPJO) is the most common congenital abnormality of the kidney and is responsible for flank pain, recurrent urinary infections, hydronephrosis and the loss of renal function. Until recently, open pyeloplasty (OP) was the standard surgical treatment modality for UPJO.However, with the development of laparoscopic devices and surgical technology, laparoscopic pyeloplasty (LP) has become a more beneficial choice for the patients with UPJO than open surgery because of the advantages of excellent visualization, minimal trauma, rapid postoperative recovery, good cosmetic result, and a nearly successful rate compared with open pyeloplasty. The first LP in children was performed in 1995. It has gained popularity for older children. LP can be performed though retroperitoneal and transperitoneal approaches. Which surgical method is better is still controversial.
- Conditions
- Urologic Diseases, Surgery
- Being tested
- Laparoscopic pyeloplasty
- Keywords
- UPJ obstruction, pediatric urology, pyeloplasty
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic pyeloplastyProcedure or surgery
Twenty patients presented with ureteropelvic junction obstruction [UPJO] will be divided into two equal groups. The first was subjected to trans-peritoneal pyeloplasty while the second was subjected to retroperitoneal pyeloplasty.
| Study group | Role | What they receive |
|---|---|---|
| Transperitoneal approach laparoscopic pyeloplasty. (TALP) | Transperitoneal approach laparoscopic pyeloplasty. (TALP) Receives: Procedure: Laparoscopic pyeloplasty | |
| Retroperitoneal Approach laparoscopic pyeloplasty. (RALP) | Retroperitoneal Approach laparoscopic pyeloplasty. (RALP) Receives: Procedure: Laparoscopic pyeloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time
Measured: From April 1, 2023 to April 1, 2024
Secondary outcomes (3)
Convergence rate
Convergence to open pyeloplasty
Measured: From April 1, 2023 to April 1, 2024
Post operative complications
Post operative complications
Measured: From April 1, 2023 to April 1, 2024
Hospital stay
Hospital stay
Measured: From April 1, 2023 to April 1, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kamel Ali Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748964
- Sponsor's protocol ID
- AKA1712
- Status last verified
- Feb 2023
- First submitted
- 18 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Surgical Approaches for Treatment of UPJ Obstruction in Children: Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05748964
- Acronym / sponsor ID
- AKA1712
- Conditions
- Urologic Diseases, Surgery
- Keywords
- UPJ obstruction, pediatric urology, pyeloplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 1 Mar 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.
This study aimed to evaluate the clinical efficacy of laparoscopic pyeloplasty (LP) for ureteropelvic junction obstruction (UPJO) via retroperitoneal and transperitoneal approaches.
Detailed description
Ureteropelvic junction obstruction (UPJO) is the most common congenital abnormality of the kidney and is responsible for flank pain, recurrent urinary infections, hydronephrosis and the loss of renal function. Until recently, open pyeloplasty (OP) was the standard surgical treatment modality for UPJO.However, with the development of laparoscopic devices and surgical technology, laparoscopic pyeloplasty (LP) has become a more beneficial choice for the patients with UPJO than open surgery because of the advantages of excellent visualization, minimal trauma, rapid postoperative recovery, good cosmetic result, and a nearly successful rate compared with open pyeloplasty. The first LP in children was performed in 1995. It has gained popularity for older children. LP can be performed though retroperitoneal and transperitoneal approaches. Which surgical method is better is still controversial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transperitoneal approach laparoscopic pyeloplasty. (TALP) | – | Procedure: Laparoscopic pyeloplastyTransperitoneal approach laparoscopic pyeloplasty. (TALP) |
| Retroperitoneal Approach laparoscopic pyeloplasty. (RALP) | – | Procedure: Laparoscopic pyeloplastyRetroperitoneal Approach laparoscopic pyeloplasty. (RALP) |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children diagnosed with unilateral ureteropelvic junction obstruction
Key inclusion criteria (2 listed)
- Age above two years.
- Unilateral UPJO.
Key exclusion criteria (4 listed)
- Age below two years.
- Bilateral UPJO.
- Recurrent UPJO.
- Malrotated kidneys and renal fusion anomalies.
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 |
|---|---|---|
| Laparoscopic pyeloplastyTwenty patients presented with ureteropelvic junction obstruction [UPJO] will be divided into two equal groups. The first was subjected to trans-peritoneal pyeloplasty while the second was subjected to retroperitoneal pyeloplasty. | Procedure or surgery | Retroperitoneal Approach laparoscopic pyeloplasty. (RALP), Transperitoneal approach laparoscopic pyeloplasty. (TALP) |
Primary outcome
Operative time
Time frame: From April 1, 2023 to April 1, 2024
Operative time
3 secondary outcomes
Convergence rate
Time frame: From April 1, 2023 to April 1, 2024
Post operative complications
Time frame: From April 1, 2023 to April 1, 2024
Hospital stay
Time frame: From April 1, 2023 to April 1, 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Diseases and Surgery, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 time (time frame: From April 1, 2023 to April 1, 2024). 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 1 Mar 2023.