Modified Antegrade Stenting in Laparoscopic Pediatric Pyeloplasty; an Optimized Approach

November 19, 2024 updated by: Mohamed Abdelghany, Cairo University

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

Completed

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

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

August 25, 2024

First Submitted That Met QC Criteria

November 17, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

August 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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