An interventional study of subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell) and open ureteral reimplantation (Lich-Gregoir) in Vesico-Ureteral Reflux, sponsored by Elsayed Salih. Completed. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2021-03-15.
Sponsored by Elsayed Salih · Not applicable, Interventional, and Treatment
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.
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:
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.
29 studies on the registry are indexed under Vesico-Ureteral Reflux; 4 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 21 interventional studies indexed under Vesico-Ureteral Reflux.
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Exclusion Criteria:
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)
extravesical ureteral reimplantation (lich-gregoir) by open surgery
Procedure: open ureteral reimplantation (Lich-Gregoir)
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.
Also known as: Dexell subureteral injection
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.
Also known as: extra-vesical (Lich-Gregoir) ureteroneocystostomy
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.
Time frame: 2 years
complications
contralateral reflux, de novo hydronephrosis, urinary tract infections and other complications.
Time frame: 2 years
median costs
median costs in US dollars compared between two groups
Time frame: 2 years
No study locations are listed for this record.
Plan to share: Yes — all IPD that underlie results in the publication including the Study Protocol Statistical Analysis Plan, Clinical Study Report, and Analytic Code.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: the data will be available 6 months after publication.
Access criteria: the data will be shared with researchers who provide a methodologically sound proposal to achieve aims in approved proposal. the mechanism of data availability include directing the approved proposal to (elsayedsalih@azhar.edu.eg) also data will be available at our university's warehouse after publication.
Data sharing details ↗ · drive.google.com
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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