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

Primary Purpose

Vesico-Ureteral Reflux

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell)
open ureteral reimplantation (Lich-Gregoir)
Sponsored by
Elsayed Salih
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vesico-Ureteral Reflux focused on measuring Extravesical Reimplantation, Subureteral Injection, Vesico-ureteral reflux, Endoscopic, Dexell

Eligibility Criteria

1 Year - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Subureteral endoscopic injection

    open ureteral reimplantation (lich-gregoir)

    Arm Description

    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.

    extravesical ureteral reimplantation (lich-gregoir) by open surgery

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    complications
    contralateral reflux, de novo hydronephrosis, urinary tract infections and other complications.
    median costs
    median costs in US dollars compared between two groups

    Full Information

    First Posted
    March 9, 2021
    Last Updated
    March 12, 2021
    Sponsor
    Elsayed Salih
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04798443
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    June 4, 2015 (Actual)
    Primary Completion Date
    August 5, 2018 (Actual)
    Study Completion Date
    June 14, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Elsayed Salih

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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: 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vesico-Ureteral Reflux
    Keywords
    Extravesical Reimplantation, Subureteral Injection, Vesico-ureteral reflux, Endoscopic, Dexell

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Subureteral endoscopic injection
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    open ureteral reimplantation (lich-gregoir)
    Arm Type
    Active Comparator
    Arm Description
    extravesical ureteral reimplantation (lich-gregoir) by open surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell)
    Other Intervention Name(s)
    Dexell subureteral injection
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    open ureteral reimplantation (Lich-Gregoir)
    Other Intervention Name(s)
    extra-vesical (Lich-Gregoir) ureteroneocystostomy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    surgical success
    Description
    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
    Secondary Outcome Measure Information:
    Title
    complications
    Description
    contralateral reflux, de novo hydronephrosis, urinary tract infections and other complications.
    Time Frame
    2 years
    Title
    median costs
    Description
    median costs in US dollars compared between two groups
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    hussein galal, MD
    Organizational Affiliation
    professor of urology- department of urology- Al-Azhar faculty of medicine
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    all IPD that underlie results in the publication including the Study Protocol Statistical Analysis Plan, Clinical Study Report, and Analytic Code.
    IPD Sharing Time Frame
    the data will be available 6 months after publication.
    IPD Sharing 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.
    IPD Sharing URL
    http://drive.google.com/drive/u/0/folders/1UiUtebWQHukhJsg6DPXdz0srJHupl43k
    Citations:
    PubMed Identifier
    23602843
    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.
    Results Reference
    result
    PubMed Identifier
    27061353
    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.
    Results Reference
    result
    PubMed Identifier
    33751917
    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.
    Results Reference
    derived

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

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