Clinical trial NCT04798443: Endoscopic Injection of Dextranomer/Hyaluronic Acid Versus Ureteral Reimplantation In Treatment of Vesicoureteral Reflux
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vesico-Ureteral Reflux
Keywords: Extravesical Reimplantation
Subureteral Injection
Vesico-ureteral reflux
Endoscopic
Dexell
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: surgical success
timeFrame: 2 years
Secondary outcomes:
measure: complications
timeFrame: 2 years
measure: median costs
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: professor of urology- department of urology- Al-Azhar faculty of medicine
name: hussein galal, MD
role: STUDY_DIRECTOR
References:
citation: Garcia-Aparicio L, Rovira J, Blazquez-Gomez E, Garcia-Garcia L, Gimenez-Llort A, Rodo J, Morales L. Randomized clinical trial comparing endoscopic treatment with dextranomer hyaluronic acid copolymer and Cohen's ureteral reimplantation for vesicoureteral reflux: long-term results. J Pediatr Urol. 2013 Aug;9(4):483-7. doi: 10.1016/j.jpurol.2013.03.003. Epub 2013 Apr 18.
citation: Karakus SC, User IR, Kilic BD, Akcaer V, Ceylan H, Ozokutan BH. The comparison of dextranomer/hyaluronic acid and polyacrylate-polyalcohol copolymers in endoscopic treatment of vesicoureteral reflux. J Pediatr Surg. 2016 Sep;51(9):1496-500. doi: 10.1016/j.jpedsurg.2016.02.092. Epub 2016 Mar 12.
citation: Salih EM, Eldamanhory H, Selmy GI, Galal HA. Comparison of Subureteral Endoscopic Injection of Dextranomer/Hyaluronic Acid and Lich-Gregoir Ureteral Reimplantation in the Treatment of Pediatric Primary Vesicoureteral Reflux: A Prospective Randomized Study. J Laparoendosc Adv Surg Tech A. 2021 Jun;31(6):719-723. doi: 10.1089/lap.2020.0973. Epub 2021 Mar 22.