HypospadiasNCT04533477
Reconstructing Forked Corpus Spongiosum in Hypospadias Repair
A study testing Reconstructing forked corpus spongiosum (FCS) and Routine standardized surgery in people with Hypospadias, run by Children's Hospital of Fudan University.
Trial summary
Hypospadias is one of the most common genital malformations in children. The high incidence of hypospadias, which occurs in 1 in 200 to 300 live births, means that it affects a large number of patients. Surgery is the only way to repair hypospadias. Over 400 techniques have been described for hypospadias repair. Read more about this study
- Who is it for?
- Ages 6 months to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypospadias
- What is being tested?
- Reconstructing forked corpus spongiosum (FCS) and Routine standardized surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 30 Sep 2023
- 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 15 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- children with primary hypospadias
- one-stage surgical repair
Who cannot join
- staged surgery repair
- micropenis
- reoperation for postoperative complications
- using testosterone or male hormones preoperatively
About this study
Official title: Application and Efficacy of Reconstructing Forked Corpus Spongiosum in Hypospadias Repair
Hypospadias is one of the most common genital malformations in children. The high incidence of hypospadias, which occurs in 1 in 200 to 300 live births, means that it affects a large number of patients. Surgery is the only way to repair hypospadias. Over 400 techniques have been described for hypospadias repair. However, the surgical success rate of hypospadias is still not ideal. Although the surgical success rate of distal hypospadias has reached more than 85%, the complications of proximal hypospadias are still as high as 30-68%. How to improve surgical skills and reduce the postoperative complications is quite a challenge for pediatric urologists.
In the preliminary clinical work, the investigators have tried to apply the technique of reconstructing forked corpus spongiosum (FCS) in hypospadias repair with urethral plate preservation. It has been confirmed that this technique was effective in reducing postoperative complications of this type of hypospadias repair. In order to promote the technology of reconstructing FCS, the investigators need to perform this technology in various types of hypospadias and evaluate its true effectiveness. Therefore, the investigators need to design a prospective, randomized, parallel-controlled, single-blind, and superior clinical trial to analyze the efficacy of reconstructing FCS in hypospadias repair.
Read more
In this study, the investigators will perform one-stage surgical repair on children with primary hypospadias by the same surgeon in Urology Department, Children's Hospital of Fudan University, Shanghai, China. Participants will be random grouped: Routine standardized surgery with reconstructing FCS group and Routine standardized surgery group. All participants will be closely followed up and regularly evaluated after surgery, including postoperative complications, HOSE objective score of cosmetic outcome and voiding function. By collecting all data and conducting statistical analysis, the investigators will evaluate the followings: (1) the correlation between the penile curvature and the development of FCS; (2) the effect of reconstructing FCS on the complications of primary hypospadias repair; (3) the effect of reconstructing FCS on the cosmetic outcome; (4) the influence of reconstructing FCS on postoperative voiding function.
Based on this clinical randomized controlled study, the investigators intend to prove the feasibility and effectiveness of the new technology of reconstructing FCS in various types of hypospadias repair. The study will provide a reliable basis for the promotion of this technology for hypospadias repair in order to improve the quality of life for children with hypospadias.
- Conditions
- Hypospadias
- Being tested
- Reconstructing forked corpus spongiosum (FCS), Routine standardized surgery
- Keywords
- Hypospadias repair, Forked corpus spongiosum
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstructing forked corpus spongiosum (FCS)Procedure or surgery
During the routine standardized surgery, the FCS should be cut off along both sides of the middle urethral plate before dissecting the glans wings and then dissected along the penile tunica albuginea closely from the near to the far side of the penis until the top of the penis head was reached. The corpus spongiosum on both sides will be reserved for the two wings of the glans. The two wings of the glans should be carefully expanded to at least the 3 o'clock and 9 o'clock positions of the penis. Some cases of small glans should be dissected to the 2 o'clock and 10 o'clock positions to close the two wings of the glans with no tension when performing glansplasty. Additionally, the original FCS on both sides should be combined at the coronal sulcus, thereby covering the surface of the new urethra.
Routine standardized surgeryProcedure or surgery
When the urethral plate can be preserved after degloving, the investigators chose the surgical method according to the width of the urethral plate. If the width of the urethral plate is ≥6 mm, tubularized incised plate (TIP) urethroplasty will be performed, whereas if the width of the urethral plate is <6 mm, the onlay island flap (ONLAY) technique will be performed. When the urethral plate can not be preserved after degloving, transverse preputial island flap urethroplasty (Duckett) will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Routine surgery with reconstructing FCS | Experimental | The participants undergo FCS reconstruction during the routine standardized surgery. Receives: Procedure: Reconstructing forked corpus spongiosum (FCS); Procedure: Routine standardized surgery |
| Routine surgery | Active comparator | The participants undergo routine standardized surgery. Receives: Procedure: Routine standardized surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if any complications including residual chordee, fistula, diverticulum, glans dehiscence, meatus stenosis, or urethral stricture happeded.
Measured: 1 to 6 months after surgery
Secondary outcomes (7)
Residual chordee
It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if residual chordee happeded.
Measured: 1 to 6 months after surgery
Fistula
It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if fistula happeded.
Measured: 1 to 6 months after surgery
Diverticulum
It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if diverticulum happeded.
Measured: 1 to 6 months after surgery
Glans dehiscence
It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if glans dehiscence happeded.
Measured: 1 to 6 months after surgery
Meatus stenosis
It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if meatus stenosis happeded.
Measured: 1 to 6 months after surgery
Urethral stricture
It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if urethral stricture happeded.
Measured: 1 to 6 months after surgery
Hypospadias objective scoring evaluation
It is an objective scoring system for evaluating the cosmetic outcome of hypospadias surgery. The scoring system is designed so that the minimum total score would be 5, corresponding to a worst score for each variable, to a maximum total of 16, equivalent to the best score for each variable.
Measured: at 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Mar 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
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.
- More trials run by Children's Hospital of Fudan 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhangbin, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533477
- Sponsor's protocol ID
- Zhangbin_001
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2020
- Last updated
- 10 Aug 2022
- 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 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Efficacy of Reconstructing Forked Corpus Spongiosum in Hypospadias Repair
- ClinicalTrials.gov ID
- NCT04533477
- Acronym / sponsor ID
- Zhangbin_001
- Conditions
- Hypospadias
- Keywords
- Hypospadias repair, Forked corpus spongiosum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 31 Aug 2020 (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.
Hypospadias is one of the most common genital malformations in children. The high incidence of hypospadias, which occurs in 1 in 200 to 300 live births, means that it affects a large number of patients. Surgery is the only way to repair hypospadias. Over 400 techniques have been described for hypospadias repair. However, the surgical success rate of hypospadias is still not ideal. Although the surgical success rate of distal hypospadias has reached more than 85%, the complications of proximal hypospadias are still as high as 30-68%. How to improve surgical skills and reduce the postoperative complications is quite a challenge for pediatric urologists.
In the preliminary clinical work, the investigators have tried to apply the technique of reconstructing forked corpus spongiosum (FCS) in hypospadias repair with urethral plate preservation. It has been confirmed that this technique was effective in reducing postoperative complications of this type of hypospadias repair. In order to promote the technology of reconstructing FCS, the investigators need to perform this technology in various types of hypospadias and evaluate its true effectiveness. Therefore, the investigators need to design a prospective, randomized, parallel-controlled, single-blind, and superior clinical trial to analyze the efficacy of reconstructing FCS in hypospadias repair.
In this study, the investigators will perform one-stage surgical repair on children with primary hypospadias by the same surgeon in Urology Department, Children's Hospital of Fudan University, Shanghai, China. Participants will be random grouped: Routine standardized surgery with reconstructing FCS group and Routine standardized surgery group. All participants will be closely followed up and regularly evaluated after surgery, including postoperative complications, HOSE objective score of cosmetic outcome and voiding function. By collecting all data and conducting statistical analysis, the investigators will evaluate the followings: (1) the correlation between the penile curvature and the development of FCS; (2) the effect of reconstructing FCS on the complications of primary hypospadias repair; (3) the effect of reconstructing FCS on the cosmetic outcome; (4) the influence of reconstructing FCS on postoperative voiding function.
Based on this clinical randomized controlled study, the investigators intend to prove the feasibility and effectiveness of the new technology of reconstructing FCS in various types of hypospadias repair. The study will provide a reliable basis for the promotion of this technology for hypospadias repair in order to improve the quality of life for children with hypospadias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine surgery with reconstructing FCS | Experimental | Procedure: Reconstructing forked corpus spongiosum (FCS), Procedure: Routine standardized surgeryThe participants undergo FCS reconstruction during the routine standardized surgery. |
| Routine surgery | Active comparator | Procedure: Routine standardized surgeryThe participants undergo routine standardized surgery. |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children with primary hypospadias
- one-stage surgical repair
Key exclusion criteria (4 listed)
- staged surgery repair
- micropenis
- reoperation for postoperative complications
- using testosterone or male hormones preoperatively
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 |
|---|---|---|
| Reconstructing forked corpus spongiosum (FCS)During the routine standardized surgery, the FCS should be cut off along both sides of the middle urethral plate before dissecting the glans wings and then dissected along the penile tunica albuginea closely from the near to the far side of the penis until the top of the penis head was reached. The corpus spongiosum on both sides will be reserved for the two wings of the glans. The two wings of the glans should be carefully expanded to at least the 3 o'clock and 9 o'clock positions of the penis. Some cases of small glans should be dissected to the 2 o'clock and 10 o'clock positions to close the two wings of the glans with no tension when performing glansplasty. Additionally, the original FCS on both sides should be combined at the coronal sulcus, thereby covering the surface of the new urethra. | Procedure or surgery | Routine surgery with reconstructing FCS |
| Routine standardized surgeryWhen the urethral plate can be preserved after degloving, the investigators chose the surgical method according to the width of the urethral plate. If the width of the urethral plate is ≥6 mm, tubularized incised plate (TIP) urethroplasty will be performed, whereas if the width of the urethral plate is <6 mm, the onlay island flap (ONLAY) technique will be performed. When the urethral plate can not be preserved after degloving, transverse preputial island flap urethroplasty (Duckett) will be performed. | Procedure or surgery | Routine surgery, Routine surgery with reconstructing FCS |
Primary outcome
Postoperative complications
Time frame: 1 to 6 months after surgery
It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if any complications including residual chordee, fistula, diverticulum, glans dehiscence, meatus stenosis, or urethral stricture happeded.
7 secondary outcomes
Residual chordee
Time frame: 1 to 6 months after surgery
Fistula
Time frame: 1 to 6 months after surgery
Diverticulum
Time frame: 1 to 6 months after surgery
Glans dehiscence
Time frame: 1 to 6 months after surgery
Meatus stenosis
Time frame: 1 to 6 months after surgery
Urethral stricture
Time frame: 1 to 6 months after surgery
Hypospadias objective scoring evaluation
Time frame: at 6 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstructing forked corpus spongiosum (FCS) and Routine standardized surgery in people with Hypospadias, run by Children's Hospital of Fudan University.
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 2 inclusion and 4 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 10 Aug 2022. 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?
Results are not available in the source record.
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?
Postoperative complications (time frame: 1 to 6 months after surgery). 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 10 Aug 2022.