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

Vesico-Ureteral Reflux Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04798443
• Other study ID #: Uro-surg./R/2015/0011
• Status: Completed
• Phase: N/A
• Start date: June 4, 2015
• Est. completion date: June 14, 2019

Study information

• Verified date: March 2021
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 14, 2019
• Est. primary completion date: August 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Vesico-Ureteral Reflux

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Elsayed Salih

References & Publications (2)

Garcia-Aparicio L, Rovira J, Blazquez-Gomez E, García-García L, Giménez-Llort A, Rodo J, Morales L. Randomized clinical trial comparing endoscopic treatment with dextranomer hyaluronic acid copolymer and Cohen's ureteral reimplantation for vesicoureteral — View Citation

Karakus SC, User IR, Kilic BD, Akçaer 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	complications	contralateral reflux, de novo hydronephrosis, urinary tract infections and other complications.	2 years
Secondary	median costs	median costs in US dollars compared between two groups	2 years