Vesico-Ureteral RefluxNCT04798443
Endoscopic Injection of Dextranomer/Hyaluronic Acid Versus Ureteral Reimplantation In Treatment of Vesicoureteral Reflux
A study testing subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell) and open ureteral reimplantation (Lich-Gregoir) in people with Vesico-Ureteral Reflux, run by Elsayed Salih.
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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Vesico-Ureteral Reflux
- What is being tested?
- subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell) and open ureteral reimplantation (Lich-Gregoir)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 4 Jun 2015to 14 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children over one year with primary Vesico-Ureteral reflux grade III and IV.
Who cannot join
- Secondary Vesico-Ureteral reflux.
- Active urinary tract infection
- Untreated voiding dysfunction.
About this study
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
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.
Read the 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.
- Conditions
- Vesico-Ureteral Reflux
- Being tested
- subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell), open ureteral reimplantation (Lich-Gregoir)
- Keywords
- Extravesical Reimplantation, Subureteral Injection, Vesico-ureteral reflux, Endoscopic, Dexell
- Medical subject headings
- Vesico-Ureteral Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell)Procedure or surgery
Also called Dexell subureteral injection
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)Procedure or surgery
Also called extra-vesical (Lich-Gregoir) ureteroneocystostomy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell) |
| open ureteral reimplantation (lich-gregoir) | Active comparator | extravesical ureteral reimplantation (lich-gregoir) by open surgery Receives: Procedure: open ureteral reimplantation (Lich-Gregoir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
complications
contralateral reflux, de novo hydronephrosis, urinary tract infections and other complications.
Measured: 2 years
median costs
median costs in US dollars compared between two groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start4 Jun 2015
- Primary completion5 Aug 2018
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vesico-Ureteral RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsayed Salih
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elsayed Salih, Al-Azhar University
- Investigators
- hussein galal, MD, Study director, professor of urology- department of urology- Al-Azhar faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798443
- Sponsor's protocol ID
- Uro-surg./R/2015/0011
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in the publication including the Study Protocol Statistical Analysis Plan, Clinical Study Report, and Analytic Code.
Publications
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.
PubMed 23602843Karakus 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.
PubMed 27061353Salih 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.
PubMed 33751917
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04798443
- Acronym / sponsor ID
- Uro-surg./R/2015/0011
- Conditions
- Vesico-Ureteral Reflux
- Keywords
- Extravesical Reimplantation, Subureteral Injection, Vesico-ureteral reflux, Endoscopic, Dexell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Elsayed SalihUniversity, hospital or other
- Study start
- 4 Jun 2015 (actual)
- Primary completion
- 5 Aug 2018 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subureteral endoscopic injection | Active comparator | Procedure: subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell)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. |
| open ureteral reimplantation (lich-gregoir) | Active comparator | Procedure: open ureteral reimplantation (Lich-Gregoir)extravesical ureteral reimplantation (lich-gregoir) by open surgery |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children over one year with primary Vesico-Ureteral reflux grade III and IV.
Key exclusion criteria (3 listed)
- Secondary Vesico-Ureteral reflux.
- Active urinary tract infection
- Untreated voiding dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell)Also: Dexell subureteral injectionThe 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. | Procedure or surgery | Subureteral endoscopic injection |
| open ureteral reimplantation (Lich-Gregoir)Also: extra-vesical (Lich-Gregoir) ureteroneocystostomyThe 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. | Procedure or surgery | open ureteral reimplantation (lich-gregoir) |
Primary outcome
surgical success
Time frame: 2 years
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 secondary outcomes
complications
Time frame: 2 years
median costs
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Results publication: PubMed 23602843Garcia-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 publication: PubMed 27061353Karakus 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.
- Derived from this study: PubMed 33751917Salih 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in the publication including the Study Protocol Statistical Analysis Plan, Clinical Study Report, and Analytic Code.
Related trials for Vesico-Ureteral Reflux
Not yet recruitingPhase 1
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
Vesico-Ureteral Reflux
RecruitingPhase 3
Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery
Other Specified Disorders of Kidney and Ureter, Benign Neoplasm of Ureter
Not yet recruiting
Diagnostic Performance of PIC Cystogram vs VCUG in Children
Pediatric Urology
Recruiting
Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography
VUR - Vesicoureteric Reflux
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hussein galal, MD study director
professor of urology- department of urology- Al-Azhar faculty of medicine
Questions about this trial
What is this clinical trial studying?
A study testing subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell) and open ureteral reimplantation (Lich-Gregoir) in people with Vesico-Ureteral Reflux, run by Elsayed Salih.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical success (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798443, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.