- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06697132
Modified Antegrade Stenting in Laparoscopic Pediatric Pyeloplasty; an Optimized Approach
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- all pediatric patients (less than 15 years old) candidates for laparoscopic dimembered pyeloplasty.
Exclusion Criteria:
• patiens who have any contraindications for pneumoperitoneum.
- Children more than 15 y old
- Children undergoing stentless pyeloplasty
- Patients undergoing pyeloplasty other than dismembered type.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Modified antegrade stenting in laparoscopic pediatric pyeloplasty
|
Modified antegrade stenting in laparoscopic pediatric pyeloplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
operative and post operative complication rate
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
operative and post operative complication rate
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- N-443-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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