HypospadiasNCT07086963
Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias?
A study testing Repaired with standard TIP repair as described by Snodgrass and Repaired with TIP with GIP using preputial graft in people with Hypospadias, run by Mohammad Daboos at 1 site in Egypt.
Trial summary
This prospective, randomized study included all patients who presented with primary hypospadias without chordee, Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. Read more about this study
- Who is it for?
- Ages 6 to 120 months, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Repaired with standard TIP repair as described by Snodgrass and Repaired with TIP with GIP using preputial graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2023to 8 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 120 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Primary hypospadias candidates for one-stage repair
- Uncircumcised cases
- Pediatric age group
- Patients with regular follow up
Who cannot join
- The presence of chordee or urethral anomalies requiring division of the urethral plate or staged repair
- Small glans < 11mm
- glanular hypospadias
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mohammad Daboos
Cairo
Mohammad Daboos, 01007578148, daboosmohammad@gmail.com
daboosmohammad@gmail.com
About this study
Official title: Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias? A Randomized Clinical Trial
This prospective, randomized study included all patients who presented with primary hypospadias without chordee, Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. In both groups the functional outcomes were primarily compared regarding meatal position, shape, and the functional outcomes of the neourethra, in addition to other complications such as UCF, wound complications, cosmetic results and the need for a second surgery.
the investigators aimed to investigate whether GIP with TIP repair is superior to TIP, as described by Snodgrass in different types of UP and to provide an overview of the technical aspects of current TIP repair practices.
Read the detailed description
This prospective, randomized study included all patients who presented with primary hypospadias without chordee.
investigators aimed to investigate whether grafted inlay patch with Tabularized Incised Plate repair is superior to TIP, as described by Snodgrass in different types of UP and to provide an overview of the technical aspects of current TIP repair practices.
Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. Patients were randomized into two groups using sealed envelopes labeled as group 1 or group 2, selected by the operating theater chief nurse. An independent statistician approved the sample size.
In both groups the functional outcomes were primarily compared regarding meatal position, shape, and the functional outcomes of the neourethra, in addition to other complications such as UCF, wound complications, cosmetic results and the need for a second surgery.
The first visit occurred on the 5th postoperative day. On 2nd week, the patients attended for catheter removal after complete healing. Calibration was performed one week after catheter removal, followed by monthly for the first six months, with HOSE scoring conducted after six months.
- Conditions
- Hypospadias
- Being tested
- Repaired with standard TIP repair as described by Snodgrass, Repaired with TIP with GIP using preputial graft
- Keywords
- Grafted TIP, Tabularized Incised Plate
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repaired with standard TIP repair as described by SnodgrassProcedure or surgery
Urethroplasty was performed over a 6-8 Fr Nelaton catheter (according to patient age and glans size) using 7/0 subcuticular continuous suture. Adequate meatus was left around the urethral catheter at the glans tip, followed by spongioplasty and a second-layer dartos fascia coverage.
Mucosal collar approximation and skin closure Glanular closure was then initiated with deep but superficial stitches using 7/0 or 6/0 polyglactin suture, and mucosal suture closure. Skin closure was achieved by preparing viable skin while avoiding midline skin closure by preparing a vascularized preputial skin flap to avoid skin coverage complications with subsequent UCF
Repaired with TIP with GIP using preputial graftProcedure or surgery
The urethral plate was deeply incised from the glans tip, extending downwards beyond the junction between the plate and the hypospadiac meatus Graft fixation The graft was then spread to cover the raw area and fixed to the edges of the urethral plate.
Urethroplasty was performed over a 6-8 Fr Nelaton catheter (according to patient age and glans size) using 7/0 subcuticular continuous suture. Adequate meatus was left around the urethral catheter at the glans tip, followed by spongioplasty and a second-layer dartos fascia coverage.
Mucosal collar approximation and skin closure Glanular closure was then initiated with deep but superficial stitches using 7/0 or 6/0 polyglactin suture, and mucosal suture closure. Skin closure was achieved by preparing viable skin while avoiding midline skin closure by preparing a vascularized preputial skin flap to avoid skin coverage complications with subsequent UCF
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Repaired with standard Tubularized incised plate repair as described by Snodgrass Receives: Procedure: Repaired with standard TIP repair as described by Snodgrass |
| Group 2 | Active comparator | Repaired with Grafted Tubularized incised plate repair using preputial graft Receives: Procedure: Repaired with TIP with GIP using preputial graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical outcomes
complications rates
Measured: 6 months
cosmetic results
cosmetic results with Hypospadias Objective Scoring Evaluation.
Measured: 6 months
Functional outcomes
Urine Flow from the neourethra
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start2 Jan 2023
- Primary completion25 Jul 2025 (estimated)
- Study completion8 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies 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
- Model description
- Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammad Daboos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad Daboos, Al-Azhar University
- Investigators
- Mohammad Daboos, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086963
- Sponsor's protocol ID
- SVU/SUR011/4/22/12/519
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Negm MA, Abdelrasheed AA, Daboos M, Khedre MM, Abdelrahman MF, Abo-Halawa NAE, Ibrahim IA, Shehata MA. Is dorsal inlay graft (DIG) with TIP repair superior to TIP alone for primary hypospadias? A randomized clinical trial. BMC Pediatr. 2026 Jan 26;26(1):62. doi: 10.1186/s12887-025-06247-7.
PubMed 41588344
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07086963
- Acronym / sponsor ID
- SVU/SUR011/4/22/12/519
- Conditions
- Hypospadias
- Keywords
- Grafted TIP, Tabularized Incised Plate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 584 participants (estimated)
- Lead sponsor
- Mohammad DaboosUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 8 Aug 2025 (estimated)
- First posted
- 25 Jul 2025 (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.
This prospective, randomized study included all patients who presented with primary hypospadias without chordee, Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. In both groups the functional outcomes were primarily compared regarding meatal position, shape, and the functional outcomes of the neourethra, in addition to other complications such as UCF, wound complications, cosmetic results and the need for a second surgery.
the investigators aimed to investigate whether GIP with TIP repair is superior to TIP, as described by Snodgrass in different types of UP and to provide an overview of the technical aspects of current TIP repair practices.
Detailed description
This prospective, randomized study included all patients who presented with primary hypospadias without chordee.
investigators aimed to investigate whether grafted inlay patch with Tabularized Incised Plate repair is superior to TIP, as described by Snodgrass in different types of UP and to provide an overview of the technical aspects of current TIP repair practices.
Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. Patients were randomized into two groups using sealed envelopes labeled as group 1 or group 2, selected by the operating theater chief nurse. An independent statistician approved the sample size.
In both groups the functional outcomes were primarily compared regarding meatal position, shape, and the functional outcomes of the neourethra, in addition to other complications such as UCF, wound complications, cosmetic results and the need for a second surgery.
The first visit occurred on the 5th postoperative day. On 2nd week, the patients attended for catheter removal after complete healing. Calibration was performed one week after catheter removal, followed by monthly for the first six months, with HOSE scoring conducted after six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Repaired with standard TIP repair as described by SnodgrassRepaired with standard Tubularized incised plate repair as described by Snodgrass |
| Group 2 | Active comparator | Procedure: Repaired with TIP with GIP using preputial graftRepaired with Grafted Tubularized incised plate repair using preputial graft |
Who may qualify
- Ages
- 6 to 120 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Primary hypospadias candidates for one-stage repair
- Uncircumcised cases
- Pediatric age group
- Patients with regular follow up
Key exclusion criteria (3 listed)
- The presence of chordee or urethral anomalies requiring division of the urethral plate or staged repair
- Small glans < 11mm
- glanular hypospadias
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 |
|---|---|---|
| Repaired with standard TIP repair as described by SnodgrassUrethroplasty was performed over a 6-8 Fr Nelaton catheter (according to patient age and glans size) using 7/0 subcuticular continuous suture. Adequate meatus was left around the urethral catheter at the glans tip, followed by spongioplasty and a second-layer dartos fascia coverage. Mucosal collar approximation and skin closure Glanular closure was then initiated with deep but superficial stitches using 7/0 or 6/0 polyglactin suture, and mucosal suture closure. Skin closure was achieved by preparing viable skin while avoiding midline skin closure by preparing a vascularized preputial skin flap to avoid skin coverage complications with subsequent UCF | Procedure or surgery | Group 1 |
| Repaired with TIP with GIP using preputial graftThe urethral plate was deeply incised from the glans tip, extending downwards beyond the junction between the plate and the hypospadiac meatus Graft fixation The graft was then spread to cover the raw area and fixed to the edges of the urethral plate. Urethroplasty was performed over a 6-8 Fr Nelaton catheter (according to patient age and glans size) using 7/0 subcuticular continuous suture. Adequate meatus was left around the urethral catheter at the glans tip, followed by spongioplasty and a second-layer dartos fascia coverage. Mucosal collar approximation and skin closure Glanular closure was then initiated with deep but superficial stitches using 7/0 or 6/0 polyglactin suture, and mucosal suture closure. Skin closure was achieved by preparing viable skin while avoiding midline skin closure by preparing a vascularized preputial skin flap to avoid skin coverage complications with subsequent UCF | Procedure or surgery | Group 2 |
Primary outcome
Surgical outcomes
Time frame: 6 months
complications rates
cosmetic results
Time frame: 6 months
cosmetic results with Hypospadias Objective Scoring Evaluation.
Functional outcomes
Time frame: 6 months
Urine Flow from the neourethra
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Derived from this study: PubMed 41588344Negm MA, Abdelrasheed AA, Daboos M, Khedre MM, Abdelrahman MF, Abo-Halawa NAE, Ibrahim IA, Shehata MA. Is dorsal inlay graft (DIG) with TIP repair superior to TIP alone for primary hypospadias? A randomized clinical trial. BMC Pediatr. 2026 Jan 26;26(1):62. doi: 10.1186/s12887-025-06247-7.
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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.
Mohammad Daboos principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repaired with standard TIP repair as described by Snodgrass and Repaired with TIP with GIP using preputial graft in people with Hypospadias, run by Mohammad Daboos 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 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Daboos, Prof (01007578148, daboosmohammad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical outcomes (time frame: 6 months). The study lists 3 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 NCT07086963, which also lists 1 linked publication.
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 25 Jul 2025.