HypospadiasNCT06187363
Redo Repair in Disrupted Hypospadias
An observational study of Hypospadias, run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial summary
Redo hypospadias repair is a challenging situation and its success depends on many factors. Several procedures could be used in such situations with variable outcomes. The investigator in this study aimed at comparing the results of these procedures Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Tubularized incised plate procedure and Other procedures
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jan 2022
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Fifty patients were included in our study; all of them have disrupted repair of hypospadias. Half of those patients were treated by TIP procedure and the other half were treated by other procedures
Who may be able to join
- Pediatric patients with disrupted hypospadias repair
Who cannot join
- Fresh cases of hypospadias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tubularized Incised Plate (TIP) Procedure Versus Other Procedures in the Repair of Disrupted Hypospadias
Redo hypospadias repair is a challenging situation and its success depends on many factors. Several procedures could be used in such situations with variable outcomes. The investigator in this study aimed at comparing the results of these procedures
Read the detailed description
Purpose: Our study compared the outcome of the tubularized incised plate urethroplasty procedure and other procedures in the case of redo hypospadias repair. Methods: The participants were categorized into those who were treated by the tubularized incised plate procedure (Group A) and those who were treated by other procedures (Group B) and the collected data were compared between the two groups. The patients were examined regularly during the postoperative period for urethral-cutaneous fistula, meatal stenosis, penile curvature, penile skin coverage, and re-disruption.
- Conditions
- Hypospadias
- Being tested
- Tubularized incised plate procedure, Other procedures
- Keywords
- Hypospadias, Redo repair, Disruption
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubularized incised plate procedureProcedure or surgery
Tubularized incised plate urethroplasty procedure
Other proceduresProcedure or surgery
Other procedures than tubularized incised plate urethroplasty procedure
| Study group | Role | What they receive |
|---|---|---|
| Patients managed by tubularized incised plate procedure | Patients with redo hypospadias repair using tubularized incised plate procedure Receives: Procedure: Tubularized incised plate procedure | |
| Patients treated by procedures other than tubularized incised plate procedure | Patients with redo hypospadias repair using other procedures Receives: Procedure: Other procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who developed post-operative meatal stricture
assessment of the position of neo-meatus in glans together with its diameter as well as the presence of stenosis as judged by urethral calibration
Measured: at 1 month, 3 months, 6 months, and at the end of the 1st year
The rate of development of recurrent post-operative chordae
The recurrence of ventral penile chordae as discovered by recurrent ventral penile curvature
Measured: at 1 month, 3 months, 6 months, and at the end of the 1st year
The incidence of development of postoperative penile skin scarring
Assessment of penile skin coverage as judged by the development of recurrent curvature, torsion and/or disfigurement
Measured: at 1 month, 3 months, 6 months, and at the end of the 1st year
The incidence of the development of failed repair as discovered by the position of the neo-meatus
Re-disruption the reposition of the neo-meatus to the previous site
Measured: at 1 month, 3 months, 6 months, and at the end of the 1st year
The incidence of the development of post-operative urethral-cutaneous fistula
The development of post-operative urethral-cutaneous fistula as judged by the development of a second urethral openning proximal to the neo-meatus
Measured: at 1 month, 3 months, 6 months, and at the end of the 1st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Jan 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Ahmed Elrouby, Egyptian Biomedical Research Network
- Investigators
- Ahmed Elrouby, MD, Principal investigator, Pediatric Surgery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187363
- Sponsor's protocol ID
- 0306287
- Status last verified
- Mar 2024
- First submitted
- 22 Sep 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tubularized Incised Plate (TIP) Procedure Versus Other Procedures in the Repair of Disrupted Hypospadias
- ClinicalTrials.gov ID
- NCT06187363
- Acronym / sponsor ID
- 0306287
- Conditions
- Hypospadias
- Keywords
- Hypospadias, Redo repair, Disruption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 2 Jan 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.
Redo hypospadias repair is a challenging situation and its success depends on many factors. Several procedures could be used in such situations with variable outcomes. The investigator in this study aimed at comparing the results of these procedures
Detailed description
Purpose: Our study compared the outcome of the tubularized incised plate urethroplasty procedure and other procedures in the case of redo hypospadias repair. Methods: The participants were categorized into those who were treated by the tubularized incised plate procedure (Group A) and those who were treated by other procedures (Group B) and the collected data were compared between the two groups. The patients were examined regularly during the postoperative period for urethral-cutaneous fistula, meatal stenosis, penile curvature, penile skin coverage, and re-disruption.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients managed by tubularized incised plate procedure | – | Procedure: Tubularized incised plate procedurePatients with redo hypospadias repair using tubularized incised plate procedure |
| Patients treated by procedures other than tubularized incised plate procedure | – | Procedure: Other proceduresPatients with redo hypospadias repair using other procedures |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fifty patients were included in our study; all of them have disrupted repair of hypospadias. Half of those patients were treated by TIP procedure and the other half were treated by other procedures
Key inclusion criteria (1 listed)
- Pediatric patients with disrupted hypospadias repair
Key exclusion criteria (1 listed)
- Fresh cases of 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 |
|---|---|---|
| Tubularized incised plate procedureTubularized incised plate urethroplasty procedure | Procedure or surgery | Patients managed by tubularized incised plate procedure |
| Other proceduresOther procedures than tubularized incised plate urethroplasty procedure | Procedure or surgery | Patients treated by procedures other than tubularized incised plate procedure |
Primary outcome
The number of participants who developed post-operative meatal stricture
Time frame: at 1 month, 3 months, 6 months, and at the end of the 1st year
assessment of the position of neo-meatus in glans together with its diameter as well as the presence of stenosis as judged by urethral calibration
The rate of development of recurrent post-operative chordae
Time frame: at 1 month, 3 months, 6 months, and at the end of the 1st year
The recurrence of ventral penile chordae as discovered by recurrent ventral penile curvature
The incidence of development of postoperative penile skin scarring
Time frame: at 1 month, 3 months, 6 months, and at the end of the 1st year
Assessment of penile skin coverage as judged by the development of recurrent curvature, torsion and/or disfigurement
The incidence of the development of failed repair as discovered by the position of the neo-meatus
Time frame: at 1 month, 3 months, 6 months, and at the end of the 1st year
Re-disruption the reposition of the neo-meatus to the previous site
The incidence of the development of post-operative urethral-cutaneous fistula
Time frame: at 1 month, 3 months, 6 months, and at the end of the 1st year
The development of post-operative urethral-cutaneous fistula as judged by the development of a second urethral openning proximal to the neo-meatus
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 19 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Hypospadias
Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
Ureteropelvic Junction Obstruction, Hypospadias
Recruiting
Worldwide Yearly Screening for Hypospadias
Hypospadias
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruiting
Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.
Perioperative Bleeding During Recurrent Hypospadias Repair
Not yet recruiting
Efficacy of PRF in Hypospadias Repair
Hypospadias
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.
Ahmed Elrouby, MD principal investigator
Pediatric Surgery department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypospadias, run by Egyptian Biomedical Research Network 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 1 inclusion and 1 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 19 Mar 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?
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?
The number of participants who developed post-operative meatal stricture (time frame: at 1 month, 3 months, 6 months, and at the end of the 1st year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2024.