NCT04798443

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

3.2 years

First QC Date

March 9, 2021

Last Update Submit

March 12, 2021

Conditions

Vesico-Ureteral Reflux

Keywords

Extravesical ReimplantationSubureteral InjectionVesico-ureteral refluxEndoscopicDexell

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • complications

    2 years

  • median costs

    2 years

Study Arms (2)

Subureteral endoscopic injection

ACTIVE COMPARATOR

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)

open ureteral reimplantation (lich-gregoir)

ACTIVE COMPARATOR

extravesical ureteral reimplantation (lich-gregoir) by open surgery

Procedure: open ureteral reimplantation (Lich-Gregoir)

Interventions

subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell)PROCEDURE

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
Subureteral endoscopic injection
open ureteral reimplantation (Lich-Gregoir)PROCEDURE

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
open ureteral reimplantation (lich-gregoir)

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children over one year with primary Vesico-Ureteral reflux grade III and IV.

You may not qualify if:

  • Secondary Vesico-Ureteral reflux.
  • Active urinary tract infection
  • Untreated voiding dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 23602843RESULT

  • 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.

    PMID: 27061353RESULT

  • 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.

    PMID: 33751917DERIVED

MeSH Terms

Conditions

Vesico-Ureteral Reflux

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • hussein galal, MD

    professor of urology- department of urology- Al-Azhar faculty of medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 15, 2021

Study Start

June 4, 2015

Primary Completion

August 5, 2018

Study Completion

June 14, 2019

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in the publication including the Study Protocol Statistical Analysis Plan, Clinical Study Report, and Analytic Code.

Shared Documents
STUDY PROTOCOL, SAP, CSR, 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.
More information