PyeloplastyNCT06142734
Laparoscopic Versus Open Pyeloplasty for Treatment of UPJO in Children.
A study testing pyeloplasty in people with Pyeloplasty, run by Ahmed Mahmoud Abdelraouf.
Trial summary
Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pyeloplasty
- What is being tested?
- pyeloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jan 2026
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children between 1-18 years , males and females with UPJ obstruction in orthotopic kidney indicated for dismembered pyeloplasty and not else
Who cannot join
- Recurrent UPJ obstruction.
- Cases that require technique other than dismembered pyeloplasty
- Patients that have contradiction to laparoscopy.
- comorbidities that prevent surgery e.g: uncorrected coagulopathy and vertebro-spinal deformity
- patient refusing participation in the study.
About this study
Official title: Laparoscopic Versus Mini-incision Open Dismembered Pyeloplasty for Treatment of Ureteropelvic Junction Obstruction in Children: a Comparative Randomized Trial.
Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. On the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay
Read the detailed description
Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Indications for surgical intervention include impaired split renal function (< 40%), a decrease of split renal function of > 10% in subsequent studies, poor drainage function after the administration of furosemide, increased anteroposterior diameter on US, and grade III and IV dilatation as defined by the Society for Fetal Urology. The open dismembered pyeloplasty was the historical gold standard repair of uretropelvic junction obstruction. Schuessler et al. introduced the first laparoscopic pyeloplasty (LP) 1993 followed by Peters et al, who performed the first pediatric laparoscopic pyeloplasty. Since then, minimally invasive pyeloplasty (MIP) -laparoscopic and robotic assisted- had an increasing interest among urologists and became widely adopted by many centers as a standard surgical intervention in UPJ obstruction; thanks to the decreased postoperative pain, short hospital stay, reduced postoperative recovery time, and comparable success rates. The high cost and long learning curve hindered generalization of MIP in all centers. On the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay . Tanaka et al. have reported that the benefits of laparoscopic pyeloplasty were evident only in older children . Till now 85% of infants are still treated with open pyeloplasty . According to the EAU guidelines 2023 "There does not seem to be any clear benefit of minimally invasive procedures in a very young child but current data are insufficient to defer a cut-off age " .
Most of the studies that compared open to LP didn't limit cases to mini-incision open pyeloplasty.
To our knowledge there is no prospective randomized study comparing laparoscopic to open pyeloplasty with mini-incision in children to date.
- Conditions
- Pyeloplasty
- Being tested
- pyeloplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyeloplastyProcedure or surgery
- For laparoscopic pyeloplasty:
- Anaesthesia: general
- Position: a 45-degree lateral decubitus position with the concerned side up. Patient is secured to the operating table. Pneumoperitoneum is adopted through a camera port lateral to the umbilicus
- extra operating ports are created at subcostal and at spinoumbilial line.
- the UPJ is transperitoneally accessed by incising the white line of Toldt and the ipsilateral colon is reflected and the proximal ureter and the pelvis are identified an mobilized
- then Anderson- Hynes pyeloplasty is carried out with insertion of nephroureterostomy or pyeloureterostomy tube.
| Study group | Role | What they receive |
|---|---|---|
| mini-incision open dismembered pyeloplasty | Other | Open surgery Receives: Procedure: pyeloplasty |
| Laparoscopic dismembered pyeloplasty | Other | Minimally invasive surgery Receives: Procedure: pyeloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
From incision to last stitch
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyeloplastyStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Mahmoud Abdelraouf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Mahmoud Abdelraouf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142734
- Sponsor's protocol ID
- pyeloplasty in children
- Status last verified
- Nov 2023
- First submitted
- 17 Sep 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Mini-incision Open Dismembered Pyeloplasty for Treatment of Ureteropelvic Junction Obstruction in Children: a Comparative Randomized Trial.
- ClinicalTrials.gov ID
- NCT06142734
- Acronym / sponsor ID
- pyeloplasty in children
- Conditions
- Pyeloplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ahmed Mahmoud AbdelraoufUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 21 Nov 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.
Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. On the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay
Detailed description
Uretropelvic junction ( UPJ ) obstruction is a common congenital disorder , but not all cases require surgical intervention. Indications for surgical intervention include impaired split renal function (< 40%), a decrease of split renal function of > 10% in subsequent studies, poor drainage function after the administration of furosemide, increased anteroposterior diameter on US, and grade III and IV dilatation as defined by the Society for Fetal Urology. The open dismembered pyeloplasty was the historical gold standard repair of uretropelvic junction obstruction. Schuessler et al. introduced the first laparoscopic pyeloplasty (LP) 1993 followed by Peters et al, who performed the first pediatric laparoscopic pyeloplasty. Since then, minimally invasive pyeloplasty (MIP) -laparoscopic and robotic assisted- had an increasing interest among urologists and became widely adopted by many centers as a standard surgical intervention in UPJ obstruction; thanks to the decreased postoperative pain, short hospital stay, reduced postoperative recovery time, and comparable success rates. The high cost and long learning curve hindered generalization of MIP in all centers. On the other hand, in children many authors reported mini incision open pyeloplasty with very small subcostal muscle splitting incision, with negligible postoperative pain and very short hospital stay . Tanaka et al. have reported that the benefits of laparoscopic pyeloplasty were evident only in older children . Till now 85% of infants are still treated with open pyeloplasty . According to the EAU guidelines 2023 "There does not seem to be any clear benefit of minimally invasive procedures in a very young child but current data are insufficient to defer a cut-off age " .
Most of the studies that compared open to LP didn't limit cases to mini-incision open pyeloplasty.
To our knowledge there is no prospective randomized study comparing laparoscopic to open pyeloplasty with mini-incision in children to date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mini-incision open dismembered pyeloplasty | Other | Procedure: pyeloplastyOpen surgery |
| Laparoscopic dismembered pyeloplasty | Other | Procedure: pyeloplastyMinimally invasive surgery |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children between 1-18 years , males and females with UPJ obstruction in orthotopic kidney indicated for dismembered pyeloplasty and not else
Key exclusion criteria (5 listed)
- Recurrent UPJ obstruction.
- Cases that require technique other than dismembered pyeloplasty
- Patients that have contradiction to laparoscopy.
- comorbidities that prevent surgery e.g: uncorrected coagulopathy and vertebro-spinal deformity
- patient refusing participation in the study.
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 |
|---|---|---|
| pyeloplasty* For laparoscopic pyeloplasty: * Anaesthesia: general * Position: a 45-degree lateral decubitus position with the concerned side up. Patient is secured to the operating table. Pneumoperitoneum is adopted through a camera port lateral to the umbilicus * extra operating ports are created at subcostal and at spinoumbilial line. * the UPJ is transperitoneally accessed by incising the white line of Toldt and the ipsilateral colon is reflected and the proximal ureter and the pelvis are identified an mobilized * then Anderson- Hynes pyeloplasty is carried out with insertion of nephroureterostomy or pyeloureterostomy tube. | Procedure or surgery | Laparoscopic dismembered pyeloplasty, mini-incision open dismembered pyeloplasty |
Primary outcome
Operative time
Time frame: baseline
From incision to last stitch
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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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?
A study testing pyeloplasty in people with Pyeloplasty, run by Ahmed Mahmoud Abdelraouf.
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 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: status not confirmed, as of the sponsor's last update on 21 Nov 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: baseline). 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 2023.