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

Study Overview
=================
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: 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. 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.

Official Title
-----------------
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

Conditions
-----------------
Vesico-Ureteral Reflux

Intervention / Treatment
-----------------
* Procedure: subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell)
* Procedure: open ureteral reimplantation (Lich-Gregoir)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subureteral endoscopic injection<br>The endoscopic procedure was done under general anesthesia, and all patients received antibiotic prophylaxis. We used the subureteral injection technique (STING), as described by O'Donnell and Puri (1984). The volume of Dx/HA was injected until ureteral orifice collapse in all patients. The needle was held for 30 s. | Procedure: subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell)<br>* 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.<br>* Other names: Dexell subureteral injection;|
| Active Comparator: open ureteral reimplantation (lich-gregoir)<br>extravesical ureteral reimplantation (lich-gregoir) by open surgery | Procedure: open ureteral reimplantation (Lich-Gregoir)<br>* 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.<br>* Other names: extra-vesical (Lich-Gregoir) ureteroneocystostomy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical success | The 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications | contralateral reflux, de novo hydronephrosis, urinary tract infections and other complications. | 2 years | 
| median costs | median costs in US dollars compared between two groups | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extravesical Reimplantation, Subureteral Injection, Vesico-ureteral reflux, Endoscopic, Dexell