- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06142734
Laparoscopic Versus Open Pyeloplasty for Treatment of UPJO in Children.
Laparoscopic Versus Mini-incision Open Dismembered Pyeloplasty for Treatment of Ureteropelvic Junction Obstruction in Children: a Comparative Randomized Trial.
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children between 1-18 years , males and females with UPJ obstruction in orthotopic kidney indicated for dismembered pyeloplasty and not else
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: mini-incision open dismembered pyeloplasty
Open surgery
|
|
Other: Laparoscopic dismembered pyeloplasty
Minimally invasive surgery
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative time
Time Frame: baseline
|
From incision to last stitch
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- pyeloplasty in children
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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