HypospadiasNCT06405763
Snodgrass Versus Grafted Snodgrass Repair in Narrow Urethral Plate in Distal Penile Hypospadias
A study testing Snodgrass repair and Snodgrass repair with graft in people with Hypospadias, run by Sohag University at 1 site in Egypt.
Trial summary
We aime to compare between Snodgrass and grafted Snodgrass repair in the outcome in distal penile hypospadias with urethral plate less than 8mm Read more about this study
- Who is it for?
- Ages 6 months to 16 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypospadias
- What is being tested?
- Snodgrass repair and Snodgrass repair with graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Dec 2023to 10 Dec 2024
- 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 6 months to 16 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Children age: > 6m up to 16y
- Distal penile hypospadias(distal shaft,coronal,subcoronal )
- mid penile hypospadias with mild chordae les 30 degree
- Urethral plate <8 mm in maximum transverse diameter before the midline urethral plate incision .Primary non-circumcised cases of hypospadias
Who cannot join
- Proximal and mid penile hypospadias with marked chordae
- previous hypospadias repair
Trial locations and contacts
1 site in 1 country.
Tarek A Siefin, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospitals
Sohag, 82511
Ahmed S Gebaly Adam, +2001002372157, ahmedshawky@med.sohag.edu.eg
About this study
We aime to compare between Snodgrass and grafted Snodgrass repair in the outcome in distal penile hypospadias with urethral plate less than 8mm
Read the detailed description
The main goal for hypospadias repair is to achieve both cosmetic and functional normality.
Several surgical techniques for hypospadias repair have been developed that depend on the site of the urethral meatus in children The effect of the urethral plate characteristics on the surgical outcome of Snodgrass repair has been studied in many series. Some documented that urethral plate width has a significant impact on the complication rates Holland and Smith reported a high complication rate in Snodgrass repair with a urethral plate width of less than 8 mm 7 The augmentation of the urethral plate either with inlay graft (DIGU, Snodgraft, or G-TIP), Onlay preputial flap, or other flaps carries a better outcome than the original TIP in many studies Others denied any effect of the narrow urethral plate on the success rate We aim in this study to determine which is better in narrow urethral plate in distal penile hypospadias, as regarding surgical and cosmetic outcomes; Snodgrass or combined inner preputial graft with Snodgrass
- Conditions
- Hypospadias
- Being tested
- Snodgrass repair, Snodgrass repair with graft
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snodgrass repairProcedure or surgery
A relaxing incision is made in the midline by using scalpel or scissors
A 6 F stent is passed into the bladder. The neourethra is closed
Snodgrass repair with graftProcedure or surgery
A relaxing incision is made in the midline by using scalpel or scissors In grafted Snodgrass repairA free graft was measured and harvested from the inner prepuce and was defatted and sutured onto the incised urethral plate The graft was sutured overlying the incision line A 6 F stent is passed into the bladder. The neourethra is closed
| Study group | Role | What they receive |
|---|---|---|
| Snodgrass repair group | Active comparator | A relaxing incision is made in the midline by using scalpel or scissors from Within the meatus to the end of the plate.
A 6 F stent is passed into the bladder. The neourethra is closed using a fine suture, 7-0 or 6-0 vicryl sutures in two-layer. Receives: Procedure: Snodgrass repair |
| Snodgrass repair with graft group | Active comparator | A relaxing incision is made in the midline by using scalpel or scissors A free graft was measured and harvested from the inner prepuce and was defatted and sutured onto the incised urethral plate after the urethral plate was incised he graft was sutured overlying the incision line A 6 F stent is passed into the bladder. The neourethra is closed Receives: Procedure: Snodgrass repair with graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Investigators want to compare between Snodgrass and combined inner preputial graft with Snodgrass in functional outcome by evaluation of the stream an ideal stream of urine (single, compact, rifled, non-dispersed urinary stream of adequate caliber) without straining.
Measured: 12 months
Cosmetic outcome
Investigators want to compare between Snodgrass and combined inner preputial graft with Snodgrass in cosmetic outcome By Hypospadias Objective penile Evaluation (HOPE) Score 1.meatus position 2.meatus shape 3.glans shape 4.penile skin shape 5.penile axis secreal 6.Torsion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start11 Dec 2023
- Primary completion10 Dec 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Shawky Gebaly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405763
- Sponsor's protocol ID
- Soh-Med-23-12-06MS
- Status last verified
- May 2024
- First submitted
- 28 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stock JA, Scherz HC, Kaplan GW. Distal hypospadias. Urol Clin North Am. 1995 Feb;22(1):131-8.
PubMed 7855949Elmoghazy H, Hussein MM, Mohamed E, Badawy A, Alsagheer G, Abd Elhamed AM. A novel technique for repair of mid-penile hypospadias using a preputial skin flap: results of 110 patients. Int Urol Nephrol. 2016 Dec;48(12):1943-1949. doi: 10.1007/s11255-016-1416-7. Epub 2016 Sep 13.
PubMed 27623810Nerli RB, Chandra S, Rai S, Dixit NS. Grafted tubularised incised plate: A right option in the management of failed mid-penile and distal hypospadias. Afr J Paediatr Surg. 2023 Jul-Sep;20(3):197-201. doi: 10.4103/ajps.ajps_19_22.
PubMed 37470555Holland AJ, Smith GH, Ross FI, Cass DT. HOSE: an objective scoring system for evaluating the results of hypospadias surgery. BJU Int. 2001 Aug;88(3):255-8. doi: 10.1046/j.1464-410x.2001.02280.x.
PubMed 11488741
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Snodgrass Versus Grafted Snodgrass Repair in Narrow Urethral Plate in Distal Penile Hypospadias
- ClinicalTrials.gov ID
- NCT06405763
- Acronym / sponsor ID
- Soh-Med-23-12-06MS
- Conditions
- Hypospadias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 8 May 2024 (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.
We aime to compare between Snodgrass and grafted Snodgrass repair in the outcome in distal penile hypospadias with urethral plate less than 8mm
Detailed description
The main goal for hypospadias repair is to achieve both cosmetic and functional normality.
Several surgical techniques for hypospadias repair have been developed that depend on the site of the urethral meatus in children The effect of the urethral plate characteristics on the surgical outcome of Snodgrass repair has been studied in many series. Some documented that urethral plate width has a significant impact on the complication rates Holland and Smith reported a high complication rate in Snodgrass repair with a urethral plate width of less than 8 mm 7 The augmentation of the urethral plate either with inlay graft (DIGU, Snodgraft, or G-TIP), Onlay preputial flap, or other flaps carries a better outcome than the original TIP in many studies Others denied any effect of the narrow urethral plate on the success rate We aim in this study to determine which is better in narrow urethral plate in distal penile hypospadias, as regarding surgical and cosmetic outcomes; Snodgrass or combined inner preputial graft with Snodgrass
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Snodgrass repair group | Active comparator | Procedure: Snodgrass repairA relaxing incision is made in the midline by using scalpel or scissors from Within the meatus to the end of the plate. A 6 F stent is passed into the bladder. The neourethra is closed using a fine suture, 7-0 or 6-0 vicryl sutures in two-layer. |
| Snodgrass repair with graft group | Active comparator | Procedure: Snodgrass repair with graftA relaxing incision is made in the midline by using scalpel or scissors A free graft was measured and harvested from the inner prepuce and was defatted and sutured onto the incised urethral plate after the urethral plate was incised he graft was sutured overlying the incision line A 6 F stent is passed into the bladder. The neourethra is closed |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children age: > 6m up to 16y
- Distal penile hypospadias(distal shaft,coronal,subcoronal )
- mid penile hypospadias with mild chordae les 30 degree
- Urethral plate <8 mm in maximum transverse diameter before the midline urethral plate incision .Primary non-circumcised cases of hypospadias
Key exclusion criteria (2 listed)
- Proximal and mid penile hypospadias with marked chordae
- previous hypospadias repair
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 |
|---|---|---|
| Snodgrass repairA relaxing incision is made in the midline by using scalpel or scissors A 6 F stent is passed into the bladder. The neourethra is closed | Procedure or surgery | Snodgrass repair group |
| Snodgrass repair with graftA relaxing incision is made in the midline by using scalpel or scissors In grafted Snodgrass repairA free graft was measured and harvested from the inner prepuce and was defatted and sutured onto the incised urethral plate The graft was sutured overlying the incision line A 6 F stent is passed into the bladder. The neourethra is closed | Procedure or surgery | Snodgrass repair with graft group |
Primary outcome
Functional outcome
Time frame: 12 months
Investigators want to compare between Snodgrass and combined inner preputial graft with Snodgrass in functional outcome by evaluation of the stream an ideal stream of urine (single, compact, rifled, non-dispersed urinary stream of adequate caliber) without straining.
Cosmetic outcome
Time frame: 12 months
Investigators want to compare between Snodgrass and combined inner preputial graft with Snodgrass in cosmetic outcome By Hypospadias Objective penile Evaluation (HOPE) Score 1.meatus position 2.meatus shape 3.glans shape 4.penile skin shape 5.penile axis secreal 6.Torsion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Results publication: PubMed 7855949Stock JA, Scherz HC, Kaplan GW. Distal hypospadias. Urol Clin North Am. 1995 Feb;22(1):131-8.
- Results publication: PubMed 27623810Elmoghazy H, Hussein MM, Mohamed E, Badawy A, Alsagheer G, Abd Elhamed AM. A novel technique for repair of mid-penile hypospadias using a preputial skin flap: results of 110 patients. Int Urol Nephrol. 2016 Dec;48(12):1943-1949. doi: 10.1007/s11255-016-1416-7. Epub 2016 Sep 13.
- Results publication: PubMed 37470555Nerli RB, Chandra S, Rai S, Dixit NS. Grafted tubularised incised plate: A right option in the management of failed mid-penile and distal hypospadias. Afr J Paediatr Surg. 2023 Jul-Sep;20(3):197-201. doi: 10.4103/ajps.ajps_19_22.
- Results publication: PubMed 11488741Holland AJ, Smith GH, Ross FI, Cass DT. HOSE: an objective scoring system for evaluating the results of hypospadias surgery. BJU Int. 2001 Aug;88(3):255-8. doi: 10.1046/j.1464-410x.2001.02280.x.
- Individual participant dataSharing planned: Undecided
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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.
Tarek A Siefin, Lecturer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snodgrass repair and Snodgrass repair with graft in people with Hypospadias, run by Sohag University at 1 site in Egypt.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed S Gebaly Adam, Resident (+2001126314479, ahmedshawky@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT06405763, which also lists 4 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 8 May 2024.