HypospadiasDFOF#TIOFNCT05144659
Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics
A study testing Double faced transverse preputial onlay island flap and Transverse inner preputial onlay island flap in people with Hypospadias, run by dr. Muhammad Abdelhafez Mahmoud, MD at 1 site in Egypt.
Trial summary
Evaluation of double faced transverse preputial onlay island flap for hypospadias repair in pediatrics. The preputial onlay island flap technique has been popularized for hypospadias repair as a result of offering a consistent combination of excellent cosmetic results and acceptable complication rates. Read more about this study
- Who is it for?
- Ages 1 year to 14 years, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Double faced transverse preputial onlay island flap and Transverse inner preputial onlay island flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 28 Feb 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 1 year to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Young male pediatric patients diagnosed as anterior, mid-penile, or posterior penile hypospadias
- with shallow and narrow urethral plate measuring less than 6 millimeters,
- without or with mild penile curvature of less than 30º after degloving of the penis.
Who cannot join
- Patients with wide urethral plate suitable for tubularized incised plate (TIP) urethroplasty,
- other types of hypospadias as penoscrotal, scrotal, perineal hypospadias,
- patients with moderate or severe penile curvature,
- recurrent cases, and
- operations done by other surgeons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics.
Evaluation of double faced transverse preputial onlay island flap for hypospadias repair in pediatrics. The preputial onlay island flap technique has been popularized for hypospadias repair as a result of offering a consistent combination of excellent cosmetic results and acceptable complication rates. Like other techniques, urethrocutaneous fistulae continue to be the most common complications, in addition to other complications, and can be attributed to the affection of flaps vascularity. Some authors describe a technique that resolves some of these problems by combining the unique benefits of the double-faced preputial flaps.
This study aimed to evaluate double faced preputial onlay island flap technique for complication rate, outcomes for urinary stream, and cosmetic results.
Read the detailed description
Type of study: prospective RCT
Review of literature:
- Different previous techniques for the repair of various levels of penile shaft hypospadias with chordee.
- Demonstration of two different well-established techniques for repair of anterior, mid-penile, and posterior penile hypospadias without or with mild curvature.
- Disadvantages of two-stage urethroplasty or technique as transverse inner preputial onlay island flap that involves dissection of the flap from its dorsal preputial tissue (as it affects the flap vascularity).
- Merits of single-stage urethroplasty double-faced preputial onlay island flap (as it combines the benefits of vascularized pedicled flap, provides better functional and cosmetic results, and low complication rate).
This study will be conducted at pediatric surgery department at Al-Houssain and Sayed Galal University Medical Centers, in the period from May 2019 to February 2021, on 68 male patients with anterior, mid-penile, and posterior penile hypospadias without or with mild curvature.
Patients will be investigated by routine laboratory tests for fitness for surgery. All of them will undergo one-stage repair using either of 2 techniques of urethroplasty; double-faced preputial onlay island flap versus transverse inner preputial onlay island flap.
Written informed consent will be signed by the parents of all participants in the study.
Institutes of the study: A multicenter study at pediatric surgery departments, Al-Azhar University Medical Centers in Cairo, Egypt.
Number of cases: Sixty-eight male patients. Time frame: 3 years.
Ethical Consideration:
The protocol will be discussed and approved by the Ethics and Institutional Review Board Committee at the investigators' hospitals. The procedures and the aim of the study will be clearly explained to the patient and the family. Written informed consent will be obtained before enrollment of the patients into the study. The family's refusal to give consent for one-stage repair is respected but does not deprive the patient of getting surgical care by two-stage repair.
Preoperative preparation:
All patients will be subjected to history taking, clinical examination, and necessary laboratory investigations (CBC, Coagulation profile, Urinalysis). Participants will receive a dose of single broad-spectrum antibiotic 30 min-1 hour before surgery.
Patients will be randomly divided (using non-transparent closed envelope randomization method) into two equal groups, each will include 34 patients; Group A will undergo double faced preputial onlay island flap and Group B will undergo transverse inner preputial onlay island flap. All operations were done by the same surgical team.
Follow-up: patients will be followed-up at OPD at 1, 3, 12, and 24 months, for incidence of any complications. HOSE score questionnaire will be used for the evaluation of outcomes.
Statistical Analysis:
Data will be presented as mean, standard deviation, number \& percentage. For qualitative data, Chi-square test (X2) is used to compare between the two groups and independent-samples t-test of significance is used when comparing between two means. The significance level is set at P <0.05. Statistical analysis will be performed using statistical package for social sciences (SPSS) version 23.0, IBM Corp, IBM SPSS Statistics for Windows, Armonk, NY, USA.
Discussion:
It will focus on one-stage repair for anterior, mid-penile, and posterior penile hypospadias without or with mild penile curvature using double-faced preputial onlay island flap in comparison to inner preputial onlay island flap.
The results obtained from this study will be compared between both groups and with those reported in the literature.
Also, it will focus on results, complications, their management, and clinical evaluation by Hypospadias Objective Scoring Evaluation (HOSE) questionnaire evaluation tool. Finally, the investigators will conclude the reconstructive technique that gives the better results and least morbidity.
- Conditions
- Hypospadias
- Being tested
- Double faced transverse preputial onlay island flap, Transverse inner preputial onlay island flap
- Keywords
- Double face;, Onlay island flap;, Inner preputial flap;, Hypospadias in pediatrics
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double faced transverse preputial onlay island flapProcedure or surgery
A well-established one-stage repair of penile hypospadias called Double faced transverse preputial onlay island flap
Transverse inner preputial onlay island flapProcedure or surgery
A second well-established one-stage repair of penile hypospadias called Transverse inner preputial onlay island flap
| Study group | Role | What they receive |
|---|---|---|
| Double faced transverse preputial onlay island flap (group A) | Active comparator | Thirty-four patients undergo double faced transverse preputial onlay island flap are categorized as (group A) Receives: Procedure: Double faced transverse preputial onlay island flap |
| transverse inner preputial onlay island flap (control group) (group B) | Active comparator | Another thirty-four patients undergo transverse inner preputial onlay island flap are categorized as the control group = (group B) Receives: Procedure: Transverse inner preputial onlay island flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethrocutaneous fistula
Urethrocutaneous fistula in number of cases \&percentage
Measured: 3 years
Flap necrosis
Flap necrosis in number of cases \&percentage
Measured: 3 years
Glannular dehiscence
Glannular dehiscence in number of cases \&percentage
Measured: 3 years
Penile rotation
Penile rotation in number of cases \&percentage
Measured: 3 years
Urethral diverticulum
Urethral diverticulum in number of cases \&percentage
Measured: 3 years
Secondary outcomes (5)
Meatal location
Meatal location in number of cases
Measured: 3 years
Meatal shape
Meatal shape in number of cases
Measured: 3 years
Urinary stream direction
Urinary stream in number of cases
Measured: 3 years
Erection
Erection straightness in number of cases
Measured: 3 years
Fistula
Fistula in number of cases
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 May 2019
- Primary completion30 Apr 2020
- Study completion28 Feb 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 68 pediatric patients will be randomly divided (using non-transparent closed envelope randomization method) into two equal groups, each will include 34 patients; Group A will undergo double-faced preputial onlay island flap and Group B will undergo transverse inner preputial onlay island flap.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dr. Muhammad Abdelhafez Mahmoud, MD, Al-Azhar University
- Investigators
- Khalid Abdelhaleem Hefney, MD, Study chair, Pediatric Surgery Department, Al-Azhar University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144659
- Sponsor's protocol ID
- Al-Azhar DFOF versus TIOF
- Acronym
- DFOF#TIOF
- Status last verified
- Dec 2021
- First submitted
- 20 Nov 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study will add to the literature
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics.
- ClinicalTrials.gov ID
- NCT05144659
- Acronym / sponsor ID
- DFOF#TIOF / Al-Azhar DFOF versus TIOF
- Conditions
- Hypospadias
- Keywords
- Double face;, Onlay island flap;, Inner preputial flap;, Hypospadias in pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MDUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 3 Dec 2021 (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.
Evaluation of double faced transverse preputial onlay island flap for hypospadias repair in pediatrics. The preputial onlay island flap technique has been popularized for hypospadias repair as a result of offering a consistent combination of excellent cosmetic results and acceptable complication rates. Like other techniques, urethrocutaneous fistulae continue to be the most common complications, in addition to other complications, and can be attributed to the affection of flaps vascularity. Some authors describe a technique that resolves some of these problems by combining the unique benefits of the double-faced preputial flaps.
This study aimed to evaluate double faced preputial onlay island flap technique for complication rate, outcomes for urinary stream, and cosmetic results.
Detailed description
Type of study: prospective RCT
Review of literature:
- Different previous techniques for the repair of various levels of penile shaft hypospadias with chordee.
- Demonstration of two different well-established techniques for repair of anterior, mid-penile, and posterior penile hypospadias without or with mild curvature.
- Disadvantages of two-stage urethroplasty or technique as transverse inner preputial onlay island flap that involves dissection of the flap from its dorsal preputial tissue (as it affects the flap vascularity).
- Merits of single-stage urethroplasty double-faced preputial onlay island flap (as it combines the benefits of vascularized pedicled flap, provides better functional and cosmetic results, and low complication rate).
This study will be conducted at pediatric surgery department at Al-Houssain and Sayed Galal University Medical Centers, in the period from May 2019 to February 2021, on 68 male patients with anterior, mid-penile, and posterior penile hypospadias without or with mild curvature.
Patients will be investigated by routine laboratory tests for fitness for surgery. All of them will undergo one-stage repair using either of 2 techniques of urethroplasty; double-faced preputial onlay island flap versus transverse inner preputial onlay island flap.
Written informed consent will be signed by the parents of all participants in the study.
Institutes of the study: A multicenter study at pediatric surgery departments, Al-Azhar University Medical Centers in Cairo, Egypt.
Number of cases: Sixty-eight male patients. Time frame: 3 years.
Ethical Consideration:
The protocol will be discussed and approved by the Ethics and Institutional Review Board Committee at the investigators' hospitals. The procedures and the aim of the study will be clearly explained to the patient and the family. Written informed consent will be obtained before enrollment of the patients into the study. The family's refusal to give consent for one-stage repair is respected but does not deprive the patient of getting surgical care by two-stage repair.
Preoperative preparation:
All patients will be subjected to history taking, clinical examination, and necessary laboratory investigations (CBC, Coagulation profile, Urinalysis). Participants will receive a dose of single broad-spectrum antibiotic 30 min-1 hour before surgery.
Patients will be randomly divided (using non-transparent closed envelope randomization method) into two equal groups, each will include 34 patients; Group A will undergo double faced preputial onlay island flap and Group B will undergo transverse inner preputial onlay island flap. All operations were done by the same surgical team.
Follow-up: patients will be followed-up at OPD at 1, 3, 12, and 24 months, for incidence of any complications. HOSE score questionnaire will be used for the evaluation of outcomes.
Statistical Analysis:
Data will be presented as mean, standard deviation, number \& percentage. For qualitative data, Chi-square test (X2) is used to compare between the two groups and independent-samples t-test of significance is used when comparing between two means. The significance level is set at P <0.05. Statistical analysis will be performed using statistical package for social sciences (SPSS) version 23.0, IBM Corp, IBM SPSS Statistics for Windows, Armonk, NY, USA.
Discussion:
It will focus on one-stage repair for anterior, mid-penile, and posterior penile hypospadias without or with mild penile curvature using double-faced preputial onlay island flap in comparison to inner preputial onlay island flap.
The results obtained from this study will be compared between both groups and with those reported in the literature.
Also, it will focus on results, complications, their management, and clinical evaluation by Hypospadias Objective Scoring Evaluation (HOSE) questionnaire evaluation tool. Finally, the investigators will conclude the reconstructive technique that gives the better results and least morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 68 pediatric patients will be randomly divided (using non-transparent closed envelope randomization method) into two equal groups, each will include 34 patients; Group A will undergo double-faced preputial onlay island flap and Group B will undergo transverse inner preputial onlay island flap.
| Arm | Type | Receives |
|---|---|---|
| Double faced transverse preputial onlay island flap (group A) | Active comparator | Procedure: Double faced transverse preputial onlay island flapThirty-four patients undergo double faced transverse preputial onlay island flap are categorized as (group A) |
| transverse inner preputial onlay island flap (control group) (group B) | Active comparator | Procedure: Transverse inner preputial onlay island flapAnother thirty-four patients undergo transverse inner preputial onlay island flap are categorized as the control group = (group B) |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Young male pediatric patients diagnosed as anterior, mid-penile, or posterior penile hypospadias
- with shallow and narrow urethral plate measuring less than 6 millimeters,
- without or with mild penile curvature of less than 30º after degloving of the penis.
Key exclusion criteria (5 listed)
- Patients with wide urethral plate suitable for tubularized incised plate (TIP) urethroplasty,
- other types of hypospadias as penoscrotal, scrotal, perineal hypospadias,
- patients with moderate or severe penile curvature,
- recurrent cases, and
- operations done by other surgeons
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 |
|---|---|---|
| Double faced transverse preputial onlay island flapA well-established one-stage repair of penile hypospadias called Double faced transverse preputial onlay island flap | Procedure or surgery | Double faced transverse preputial onlay island flap (group A) |
| Transverse inner preputial onlay island flapA second well-established one-stage repair of penile hypospadias called Transverse inner preputial onlay island flap | Procedure or surgery | transverse inner preputial onlay island flap (control group) (group B) |
Primary outcome
Urethrocutaneous fistula
Time frame: 3 years
Urethrocutaneous fistula in number of cases \&percentage
Flap necrosis
Time frame: 3 years
Flap necrosis in number of cases \&percentage
Glannular dehiscence
Time frame: 3 years
Glannular dehiscence in number of cases \&percentage
Penile rotation
Time frame: 3 years
Penile rotation in number of cases \&percentage
Urethral diverticulum
Time frame: 3 years
Urethral diverticulum in number of cases \&percentage
5 secondary outcomes
Meatal location
Time frame: 3 years
Meatal shape
Time frame: 3 years
Urinary stream direction
Time frame: 3 years
Erection
Time frame: 3 years
Fistula
Time frame: 3 years
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 17 Dec 2021.
- Individual participant dataSharing planned: Yes. Data will be available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study will add to the literature
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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.
Khalid Abdelhaleem Hefney, MD study chair
Pediatric Surgery Department, Al-Azhar University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double faced transverse preputial onlay island flap and Transverse inner preputial onlay island flap in people with Hypospadias, run by dr. Muhammad Abdelhafez Mahmoud, MD 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 3 inclusion and 5 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 17 Dec 2021. 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?
Urethrocutaneous fistula (time frame: 3 years). 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 17 Dec 2021.