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Endoscopic Injection of Dextranomer/Hyaluronic Acid Versus Ureteral Reimplantation In Treatment of Vesicoureteral Reflux

NCT04798443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-03-15

No results posted yet for this study

Summary

In this study, the investigators aim to compare the outcomes of Dextranomer/hyaluronic acid (Dexell®) and extravesical reimplantation (Lich- Gregoir) procedures for primary vesicoureteral reflux (VUR) grades III and IV in children.

Conditions

  • Vesico-Ureteral Reflux

Interventions

PROCEDURE

subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell)

The subureteral endoscopic injection was done under general anesthesia. the investigators used the subureteral injection technique (STING), as described by O'Donnell and Puri. The volume of Dexell was injected until ureteral orifice collapse in all patients. The needle was held for 30 s.

PROCEDURE

open ureteral reimplantation (Lich-Gregoir)

The juxtavesical ureter is dissected by open surgery and a submucosal groove is created extending laterally from the ureteral hiatus along the course of the ureter. The ureter is placed in the groove and the detrusor is closed over the ureter with ureteric stent fixation for 21 days. the surgical wound is closed in layers. Urethral catheter for bladder drainage for 3-5 days.

Sponsors & Collaborators

  • Elsayed Salih

    lead OTHER

Principal Investigators

  • hussein galal, MD · professor of urology- department of urology- Al-Azhar faculty of medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-04
Primary Completion
2018-08-05
Completion
2019-06-14

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04798443 on ClinicalTrials.gov