Urologic DiseasesNCT05817760
Z-plasty and Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web
A study testing Z-scrotoplasty and Heineke-Mikulicz scrotoplasty in people with Urologic Diseases, run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the surgical outcome of Z-scrotoplasty versus Heineke-Mikulicz scrotoplasty in the management of congenital penoscrotal web in pediatric age group. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Urologic Diseases
- What is being tested?
- Z-scrotoplasty and Heineke-Mikulicz scrotoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jan 2021
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with congenital penoscrotal web in the pediatric age group
Who cannot join
- Patients with any penile anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Z-plasty Versus Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web in Pediatric Age Group
The goal of this clinical trial is to compare the surgical outcome of Z-scrotoplasty versus Heineke-Mikulicz scrotoplasty in the management of congenital penoscrotal web in pediatric age group.
The main question[s] it aims to answer are:
- Question 1: Is there a difference in the surgical outcome between using Z-scrotoplasty and Heinke Miculickz scrotoplasty in the management of congenital penoscrotal web?] Participants will be divided into two groups; Group A treated by Z-scrotoplasty and Group B treated by Heineke Miculickz scrotoplasty.
Read the detailed description
Background: The penoscrotal web may be congenital or acquired after excessive removal of ventral skin during circumcision. There are several previously described surgical techniques for the treatment of congenital webbed penis without a clear comparison between their outcomes. Purpose: the objective of our study was to compare the surgical results of Z-scrotoplasty and Heineke-Mikulicz scrotoplasty in the treatment of congenital webbed penis. Patients \& Methods: Our prospective study included 40 uncircumcised patients presented with a webbed penis. They were divided into group A which was treated by Z-scrotoplasty and group B which was treated by Heineke-Mikulicz scrotoplasty.
- Conditions
- Urologic Diseases
- Being tested
- Z-scrotoplasty, Heineke-Mikulicz scrotoplasty
- Keywords
- Penoscrotal web, Z-scrotoplasty, Heineke-Mikulicz
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-scrotoplastyProcedure or surgery
Z shape incision of the penoscrotal web and closure
Heineke-Mikulicz scrotoplastyProcedure or surgery
Transverse incision of the penoscrotal web with vertical closure
| Study group | Role | What they receive |
|---|---|---|
| Z-scrotoplasty | Experimental | Pediatric patients with congenital penoscrotal web who will be treated by Z-scrotoplasty Receives: Procedure: Z-scrotoplasty |
| Heineke-Mikulicz scrotoplasty | Experimental | Pediatric patients with congenital penoscrotal web who will be treated by Heineke-Mikulicz scrotoplasty Receives: Procedure: Heineke-Mikulicz scrotoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who developed post-operative penile edema, hematoma, adequate skin coverage and wound contracture with recurrent webbing will be assessed
Post-operative follow up for the detection of penile edema, hematoma, skin coverage and the development of any wound contracture and consequently recurrent webbing
Measured: One post-operative year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
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 Urologic DiseasesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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, Study director, Pediatric Surgery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817760
- Sponsor's protocol ID
- 0305354
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elrouby A. Evaluation of Z-plasty versus Heineke-Mikulicz scrotoplasty in the management of penoscrotal web in pediatric age group. BMC Urol. 2024 Mar 22;24(1):66. doi: 10.1186/s12894-024-01450-7.
PubMed 38519937
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Z-plasty Versus Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web in Pediatric Age Group
- ClinicalTrials.gov ID
- NCT05817760
- Acronym / sponsor ID
- 0305354
- Conditions
- Urologic Diseases
- Keywords
- Penoscrotal web, Z-scrotoplasty, Heineke-Mikulicz
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 18 Apr 2023 (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.
The goal of this clinical trial is to compare the surgical outcome of Z-scrotoplasty versus Heineke-Mikulicz scrotoplasty in the management of congenital penoscrotal web in pediatric age group.
The main question[s] it aims to answer are:
- Question 1: Is there a difference in the surgical outcome between using Z-scrotoplasty and Heinke Miculickz scrotoplasty in the management of congenital penoscrotal web?] Participants will be divided into two groups; Group A treated by Z-scrotoplasty and Group B treated by Heineke Miculickz scrotoplasty.
Detailed description
Background: The penoscrotal web may be congenital or acquired after excessive removal of ventral skin during circumcision. There are several previously described surgical techniques for the treatment of congenital webbed penis without a clear comparison between their outcomes. Purpose: the objective of our study was to compare the surgical results of Z-scrotoplasty and Heineke-Mikulicz scrotoplasty in the treatment of congenital webbed penis. Patients \& Methods: Our prospective study included 40 uncircumcised patients presented with a webbed penis. They were divided into group A which was treated by Z-scrotoplasty and group B which was treated by Heineke-Mikulicz scrotoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Z-scrotoplasty | Experimental | Procedure: Z-scrotoplastyPediatric patients with congenital penoscrotal web who will be treated by Z-scrotoplasty |
| Heineke-Mikulicz scrotoplasty | Experimental | Procedure: Heineke-Mikulicz scrotoplastyPediatric patients with congenital penoscrotal web who will be treated by Heineke-Mikulicz scrotoplasty |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with congenital penoscrotal web in the pediatric age group
Key exclusion criteria (1 listed)
- Patients with any penile anomalies
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 |
|---|---|---|
| Z-scrotoplastyZ shape incision of the penoscrotal web and closure | Procedure or surgery | Z-scrotoplasty |
| Heineke-Mikulicz scrotoplastyTransverse incision of the penoscrotal web with vertical closure | Procedure or surgery | Heineke-Mikulicz scrotoplasty |
Primary outcome
Number of patients who developed post-operative penile edema, hematoma, adequate skin coverage and wound contracture with recurrent webbing will be assessed
Time frame: One post-operative year
Post-operative follow up for the detection of penile edema, hematoma, skin coverage and the development of any wound contracture and consequently recurrent webbing
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 18 Apr 2023.
- Derived from this study: PubMed 38519937Elrouby A. Evaluation of Z-plasty versus Heineke-Mikulicz scrotoplasty in the management of penoscrotal web in pediatric age group. BMC Urol. 2024 Mar 22;24(1):66. doi: 10.1186/s12894-024-01450-7.
- 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.
Ahmed Elrouby, MD study director
Pediatric Surgery department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Z-scrotoplasty and Heineke-Mikulicz scrotoplasty in people with Urologic Diseases, 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 18 Apr 2023. 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?
Number of patients who developed post-operative penile edema, hematoma, adequate skin coverage and wound contracture with recurrent webbing will be assessed (time frame: One post-operative year). 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 NCT05817760, 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 18 Apr 2023.