Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798443
Status:
COMPLETED
Last Update Posted:
2021-03-15
First Post:
2021-03-09
Brief Title:
Endoscopic Injection of DextranomerHyaluronic Acid Versus Ureteral Reimplantation In Treatment of Vesicoureteral Reflux
Sponsor:
Elsayed Salih
Organization:
Al-Azhar University
Study Overview
Official Title:
Comparison of Subureteral Endoscopic Injection of DextranomerHyaluronic Acid and Lich-Gregoir Ureteral Reimplantation In the Treatment of Pediatric Primary Vesicoureteral Reflux Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the investigators aim to compare the outcomes of Dextranomerhyaluronic 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 dextranomerhyaluronic 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 dextranomerhyaluronic 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 ODonnell and Puri The volume of dextranomerhyaluronic 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 CS renal ultrasound at 13 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
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 dextranomerhyaluronic 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 ODonnell and Puri The volume of dextranomerhyaluronic 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 CS renal ultrasound at 13 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None