UPJ - Ureteropelvic ObstructionNCT06697132
Modified Antegrade Stenting in Laparoscopic Pediatric Pyeloplasty; an Optimized Approach
A study testing laparoscopic dismembered pyeloplasty in people with UPJ - Ureteropelvic Obstruction, run by Cairo University.
Trial summary
Background and Rationale For decades, the use of transanastomotic stents following dismembered pyeloplasty has been controversial. However classically, many surgeons used to insert an indwelling DJ stent to secure the ureteropelvic anastomosis. Read more about this study
- Who is it for?
- Ages 3 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- UPJ - Ureteropelvic Obstruction
- What is being tested?
- laparoscopic dismembered pyeloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2013to 1 Aug 2021
- 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 3 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- all pediatric patients (less than 15 years old) candidates for laparoscopic dimembered pyeloplasty.
Who cannot join
- • patiens who have any contraindications for pneumoperitoneum.
- Children more than 15 y old
- Children undergoing stentless pyeloplasty
- Patients undergoing pyeloplasty other than dismembered type.
About this study
Background and Rationale For decades, the use of transanastomotic stents following dismembered pyeloplasty has been controversial. However classically, many surgeons used to insert an indwelling DJ stent to secure the ureteropelvic anastomosis. During the laparoscopic pyeloplasty, the DJ can be inserted using different approaches. Neither of these approaches has absolute benefits , nor is free from drawbacks.
Objective: Whether the retrograde or antegrade approach of stenting is superior in laparoscopic pyeloplasty remains a great controversy. Each technique has its advantages and disadvantages. We tried in this study to optimize the way of stenting, taking the advantages of both approaches and avoiding their disadvantages.
Read the detailed description
Objective: Whether the retrograde or antegrade approach of stenting is superior in laparoscopic pyeloplasty remains a great controversy. Each technique has its advantages and disadvantages. We tried in this study to optimize the way of stenting, taking the advantages of both approaches and avoiding their disadvantages.
Methods: Between March 2013 and August 2021, 75 patients less than 15 years of age candidate for laparoscopic pyeloplasty were included in the study. All cases were done by the same surgeon in our institute. At first, a retrograde study was done, and an open-tip ureteric catheter was inserted just below the pelviureteric junction. Putting the ureteric catheter just below the pelviureteric junction makes the whole procedure easier. After proper dissection, the anterior wall of the pelvis is incised and continuing the ureteric spatulation on its lateral aspect. Before the complete division of the ureter, the first stitch is taken between the angle of ureteric spatulation and the lower angle of the pelvis. After completing the posterior wall anastomosis, a guide wire is introduced through the ureteric catheter, grasped gently, and pulled out through the uppermost port, and the ureteric catheter is then removed. With the proximal end of the guide wire passing through the upper port and its distal end coming outside the urethra, the DJ is passed in an antegrade manner while pulling on the urethral catheter balloon to close the bladder neck.
- Conditions
- UPJ - Ureteropelvic Obstruction
- Being tested
- laparoscopic dismembered 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.
laparoscopic dismembered pyeloplastyProcedure or surgery
Modified antegrade stenting in laparoscopic pediatric pyeloplasty
| Study group | Role | What they receive |
|---|---|---|
| Modified antegrade stenting in laparoscopic pediatric pyeloplasty | Experimental | Not described Receives: Procedure: laparoscopic dismembered pyeloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative and post operative complication rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Mar 2013
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UPJ - Ureteropelvic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelghany, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697132
- Sponsor's protocol ID
- N-443-2023
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Antegrade Stenting in Laparoscopic Pediatric Pyeloplasty; an Optimized Approach
- ClinicalTrials.gov ID
- NCT06697132
- Acronym / sponsor ID
- N-443-2023
- Conditions
- UPJ - Ureteropelvic Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 20 Nov 2024 (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.
Background and Rationale For decades, the use of transanastomotic stents following dismembered pyeloplasty has been controversial. However classically, many surgeons used to insert an indwelling DJ stent to secure the ureteropelvic anastomosis. During the laparoscopic pyeloplasty, the DJ can be inserted using different approaches. Neither of these approaches has absolute benefits , nor is free from drawbacks.
Objective: Whether the retrograde or antegrade approach of stenting is superior in laparoscopic pyeloplasty remains a great controversy. Each technique has its advantages and disadvantages. We tried in this study to optimize the way of stenting, taking the advantages of both approaches and avoiding their disadvantages.
Detailed description
Objective: Whether the retrograde or antegrade approach of stenting is superior in laparoscopic pyeloplasty remains a great controversy. Each technique has its advantages and disadvantages. We tried in this study to optimize the way of stenting, taking the advantages of both approaches and avoiding their disadvantages.
Methods: Between March 2013 and August 2021, 75 patients less than 15 years of age candidate for laparoscopic pyeloplasty were included in the study. All cases were done by the same surgeon in our institute. At first, a retrograde study was done, and an open-tip ureteric catheter was inserted just below the pelviureteric junction. Putting the ureteric catheter just below the pelviureteric junction makes the whole procedure easier. After proper dissection, the anterior wall of the pelvis is incised and continuing the ureteric spatulation on its lateral aspect. Before the complete division of the ureter, the first stitch is taken between the angle of ureteric spatulation and the lower angle of the pelvis. After completing the posterior wall anastomosis, a guide wire is introduced through the ureteric catheter, grasped gently, and pulled out through the uppermost port, and the ureteric catheter is then removed. With the proximal end of the guide wire passing through the upper port and its distal end coming outside the urethra, the DJ is passed in an antegrade manner while pulling on the urethral catheter balloon to close the bladder neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified antegrade stenting in laparoscopic pediatric pyeloplasty | Experimental | Procedure: laparoscopic dismembered pyeloplasty |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all pediatric patients (less than 15 years old) candidates for laparoscopic dimembered pyeloplasty.
Key exclusion criteria (4 listed)
- • patiens who have any contraindications for pneumoperitoneum.
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 dismembered pyeloplastyModified antegrade stenting in laparoscopic pediatric pyeloplasty | Procedure or surgery | Modified antegrade stenting in laparoscopic pediatric pyeloplasty |
Primary outcome
operative and post operative complication rate
Time frame: one year
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 21 Nov 2024.
- Individual participant dataSharing planned: No
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?
A study testing laparoscopic dismembered pyeloplasty in people with UPJ - Ureteropelvic Obstruction, run by Cairo 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 1 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: finished, as of the sponsor's last update on 21 Nov 2024. 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?
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?
operative and post operative complication rate (time frame: one year). 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 21 Nov 2024.