Endoscopic Injection of Dextranomer/Hyaluronic Acid Versus Ureteral Reimplantation In Treatment of Vesicoureteral Reflux
Condition: Vesico-Ureteral Reflux
MeSH terms: Gastroesophageal Reflux; Vesico-Ureteral Reflux
Study type: Interventional

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.
    

Intervention name(s): subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell); open ureteral reimplantation (Lich-Gregoir)
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Other intervention name(s): Dexell subureteral injection; extra-vesical (Lich-Gregoir) ureteroneocystostomy
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extravesical Reimplantation; Subureteral Injection; Vesico-ureteral reflux; Endoscopic; Dexell