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

Comparison of Subureteral Endoscopic Injection of Dextranomer/Hyaluronic Acid and Lich-Gregoir Ureteral Reimplantation In the Treatment of Pediatric Primary Vesicoureteral Reflux: Prospective Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04798443
Enrollment
60
Registered
2021-03-15
Start date
2015-06-04
Completion date
2019-06-14
Last updated
2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vesico-Ureteral Reflux

Keywords

Extravesical Reimplantation, Subureteral Injection, Vesico-ureteral reflux, Endoscopic, Dexell

Brief 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.

Detailed description

A total of 60 patients with 93 renal unites were prospectively enrolled in a comparative intervention study. Patients were randomly allocated by simple randomization at a 1: 1 ratio into 2 groups, where dextranomer/hyaluronic acid (Dexell) injection was used in Group A (30 patients with 45 renal units) and Lich-Gregoir in Group B (30 patients with 48 renal units). Children over 1 year with primary VUR grade III & IV based on recent VCUG included in the study. This study and method of attaining consent were approved by clinical research and ethical committee of our department. Written consents were taken from patients' guardians involved in the study. the investigators offered all of patients with symptomatic VUR entry into a prospective protocol between June 2015 and February 2018 at the Urology Department, Al Hussein University Hospital, Al-Azhar University. Surgical Technique: 1. dextranomer/hyaluronic acid injection: The endoscopic procedure was done under general anesthesia, and all patients received antibiotic prophylaxis. the investigators used the subureteral injection technique (STING), as described by O'Donnell and Puri . The volume of dextranomer/hyaluronic acid was injected until ureteral orifice collapse in all patients. The needle was held for 30 s. 2. ureteral reimplantation (lich-gregoir): The juxtavesical ureter is dissected 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. Urethral catheter for bladder drainage for 3-5 days. Postoperative Care All children were maintained on prophylaxis until resolution of reflux documented on the VCUG. Patients were assessed by general examination, serial urinalysis and urine C.S. renal ultrasound at 1,3 months and at 1 year after the procedure and a VCUG at 3-6 months. MRU at 1 year. DMSA scintigraphy were done at 6 months after the procedure. the investigators analyzed the outcome in these 2 surgical groups in terms of success rate at short-term follow-up, contralateral reflux, de novo hydronephrosis, urinary tract infections and complications. The investigators considered that a patient was cured from reflux when there was no VUR on VCUG.

Interventions

PROCEDUREsubureteral 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.

PROCEDUREopen 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

Elsayed Salih
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

• Children over one year with primary Vesico-Ureteral reflux grade III and IV.

Exclusion criteria

* Secondary Vesico-Ureteral reflux. * Active urinary tract infection * Untreated voiding dysfunction.

Design outcomes

Primary

MeasureTime frameDescription
surgical success2 yearsThe outcomes between both groups were analyzed according to surgical success rate. The child was considered to have been cured when there was no reflux on VCUG.

Secondary

MeasureTime frameDescription
complications2 yearscontralateral reflux, de novo hydronephrosis, urinary tract infections and other complications.
median costs2 yearsmedian costs in US dollars compared between two groups

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026