Hypospadias, PenoscrotalDuckettvDFPFNCT04605068
Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee
A study testing Transverse preputial island flap (Duckett's technique) and Double-faced preputial flap (DFPF) in people with Hypospadias, Penoscrotal and Chordee, run by dr. Muhammad Abdelhafez Mahmoud, MD.
Trial summary
The purpose of this study is to compare the outcomes and complications of the transverse preputial island flap (Duckett's procedure) to those of double-faced preputial flap (DFPF) for one-stage repair of penoscrotal hypospadias with chordee, in addition to clinical functional evaluation by estimated urine flow. Read more about this study
- Who is it for?
- Ages 6 months to 14 years, men only
- Conditions the study is for
- Hypospadias, Penoscrotal, Chordee
- What is being tested?
- Transverse preputial island flap (Duckett's technique) and Double-faced preputial flap (DFPF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Mar 2020
- 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 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Uncircumcised male patients with penoscrotal hypospadias,
- rudimentary urethral plate
- with moderate-to-severe chordee and
- no history of previous repair
Who cannot join
- circumcised patients,
- patients with other types of hypospadias such as glanular or distal shaft or
- with mild chordee corrected after penile degloving,
- recurrent hypospadias, or
- lost to follow-up.
About this study
Official title: Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee: A Randomized Controlled Trial
The purpose of this study is to compare the outcomes and complications of the transverse preputial island flap (Duckett's procedure) to those of double-faced preputial flap (DFPF) for one-stage repair of penoscrotal hypospadias with chordee, in addition to clinical functional evaluation by estimated urine flow.
Read the detailed description
Type of study: RCT
Review of literature:
- Different modalities of urethroplasty for repair of proximal hypospadias with chordee (two-stage repair, one-stage repair, flap, graft).
- Disadvantages of two-stage urethroplasty for proximal hypospadias with chordee..
- Merits of one-stage urethroplasty for proximal hypospadias with chordee. This is a prospective randomized controlled study conducted at pediatric surgery department, Al-Houssain \& New Damietta Al-Azhar University Hospitals, from March 2014 to March 2020, on 144 male patients with penoscrotal hypospadias with chordee. 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 tubularized preputial flap; Duckett's versus DFPF. Written informed consent will be obtained from parents of all participants in the study.
Institutes of the study:
A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals in Cairo and New Damietta. Number of cases: One-hundred-Forty four male patients. Time frame: period of 6 years.
Ethical Consideration:
The protocol will be discussed and approved for clinical study by the Ethical Research Committee at the principal investigator's hospital. The procedures and the aim of the study will be clearly explained to the patient and the family. A written informed consent will be obtained before enrollment of the patients into the study. The family refusal to give consent for one-stage repair is respected but does not deprive the patient from 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, Liver and Renal Function tests, Electrolytes Panel, Urinalysis). They will receive a dose of single broad-spectrum antibiotic 30 min-1 hour before surgery. Patients will be randomly divided (using the computer-generated randomization table) into two equal groups, each will include 72 patients; Group I will undergo transverse preputial island flap (Duckett's technique) and Group II will undergo double-faced preputial flap (DFPF). Both techniques will be done by all members of the surgical team equally.
Follow-up:
Patients will be followed-up at OPD.
Statistical Analysis:
Data were collected using a data collecting sheets (annexes) and were analyzed using the statistical package for social sciences (SPSS) version 24.0 (IBM SPSS Statistics for Windows, IBM Corp, Armonk, NY, USA). Continuous variables were expressed as mean±standard deviation (SD), range, and average and categorical variables were expressed as frequency count \& percentage. Fisher's exact test was used for comparison of frequency counts/percentage. A two-sided p-value < 0.05 was considered statistically significant.
Discussion:
It will focus on one-stage urethroplasty using the preputial flap for proximal hypospadias with chordee. The results obtained from this study will be compared between both group and with those reported in the literature.
Also, it will focus on results, complications, their management, and clinical evaluation by estimated urine caliber and micturition time. At the end, the investigators will conclude the reconstructive technique that gives the better results and least morbidity.
- Conditions
- Hypospadias, Penoscrotal, Chordee
- Being tested
- Transverse preputial island flap (Duckett's technique), Double-faced preputial flap (DFPF)
- Keywords
- Penoscrotal Hypospadias, Chordee, Tubularized Double-Faced Preputial Flap, Duckett's Urethroplasty, One-Stage Repair
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse preputial island flap (Duckett's technique)Procedure or surgery
Double-faced preputial flap (DFPF)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transverse preputial island flap (Duckett's technique) | Active comparator | 72 patients (Group I) with penoscrotal hypospadias with chordee Receives: Procedure: Transverse preputial island flap (Duckett's technique) |
| Double-faced preputial flap (DFPF) | Active comparator | 72 patients (Group II) with penoscrotal hypospadias with chordee Receives: Procedure: Double-faced preputial flap (DFPF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethrocutaneous fistula (number & percent)
Urethrocutaneous fistula
Measured: 2 years
Meatal stenosis (number & percent)
Meatal stenosis
Measured: 2 years
Urethral stricture (number & percent)
Urethral stricture
Measured: 3 years
Secondary outcomes (5)
Penile rotation (number & percent)
Penile rotation
Measured: 3 years
Urine stream (in caliber)
Urine stream
Measured: 3 years
Urine stream (in meters)
Urine stream
Measured: 3 years
Micturition time (in seconds)
Micturition time
Measured: 3 years
Follow-up period (in months)
Follow-up period
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study startMar 2014
- Primary completionSep 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypospadias, PenoscrotalStudies 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
- 144 patients will be randomly divided (using the computer-generated randomization table) into two equal groups, each will include 72 patients; Group I will undergo transverse preputial island flap (Duckett's technique) and Group II will undergo double-faced preputial flap (DFPF).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 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
- Mohamed M Shahin, MD, Principal investigator, Al-Azhar New Damietta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605068
- Sponsor's protocol ID
- Al-Azhar Duckett's versus DFPF
- Acronym
- DuckettvDFPF
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 27 Oct 2020
- 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 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04605068
- Acronym / sponsor ID
- DuckettvDFPF / Al-Azhar Duckett's versus DFPF
- Conditions
- Hypospadias, Penoscrotal, Chordee
- Keywords
- Penoscrotal Hypospadias, Chordee, Tubularized Double-Faced Preputial Flap, Duckett's Urethroplasty, One-Stage Repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MDUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 27 Oct 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.
The purpose of this study is to compare the outcomes and complications of the transverse preputial island flap (Duckett's procedure) to those of double-faced preputial flap (DFPF) for one-stage repair of penoscrotal hypospadias with chordee, in addition to clinical functional evaluation by estimated urine flow.
Detailed description
Type of study: RCT
Review of literature:
- Different modalities of urethroplasty for repair of proximal hypospadias with chordee (two-stage repair, one-stage repair, flap, graft).
- Disadvantages of two-stage urethroplasty for proximal hypospadias with chordee..
- Merits of one-stage urethroplasty for proximal hypospadias with chordee. This is a prospective randomized controlled study conducted at pediatric surgery department, Al-Houssain \& New Damietta Al-Azhar University Hospitals, from March 2014 to March 2020, on 144 male patients with penoscrotal hypospadias with chordee. 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 tubularized preputial flap; Duckett's versus DFPF. Written informed consent will be obtained from parents of all participants in the study.
Institutes of the study:
A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals in Cairo and New Damietta. Number of cases: One-hundred-Forty four male patients. Time frame: period of 6 years.
Ethical Consideration:
The protocol will be discussed and approved for clinical study by the Ethical Research Committee at the principal investigator's hospital. The procedures and the aim of the study will be clearly explained to the patient and the family. A written informed consent will be obtained before enrollment of the patients into the study. The family refusal to give consent for one-stage repair is respected but does not deprive the patient from 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, Liver and Renal Function tests, Electrolytes Panel, Urinalysis). They will receive a dose of single broad-spectrum antibiotic 30 min-1 hour before surgery. Patients will be randomly divided (using the computer-generated randomization table) into two equal groups, each will include 72 patients; Group I will undergo transverse preputial island flap (Duckett's technique) and Group II will undergo double-faced preputial flap (DFPF). Both techniques will be done by all members of the surgical team equally.
Follow-up:
Patients will be followed-up at OPD.
Statistical Analysis:
Data were collected using a data collecting sheets (annexes) and were analyzed using the statistical package for social sciences (SPSS) version 24.0 (IBM SPSS Statistics for Windows, IBM Corp, Armonk, NY, USA). Continuous variables were expressed as mean±standard deviation (SD), range, and average and categorical variables were expressed as frequency count \& percentage. Fisher's exact test was used for comparison of frequency counts/percentage. A two-sided p-value < 0.05 was considered statistically significant.
Discussion:
It will focus on one-stage urethroplasty using the preputial flap for proximal hypospadias with chordee. The results obtained from this study will be compared between both group and with those reported in the literature.
Also, it will focus on results, complications, their management, and clinical evaluation by estimated urine caliber and micturition time. At the end, 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
- 144 patients will be randomly divided (using the computer-generated randomization table) into two equal groups, each will include 72 patients; Group I will undergo transverse preputial island flap (Duckett's technique) and Group II will undergo double-faced preputial flap (DFPF).
| Arm | Type | Receives |
|---|---|---|
| Transverse preputial island flap (Duckett's technique) | Active comparator | Procedure: Transverse preputial island flap (Duckett's technique)72 patients (Group I) with penoscrotal hypospadias with chordee |
| Double-faced preputial flap (DFPF) | Active comparator | Procedure: Double-faced preputial flap (DFPF)72 patients (Group II) with penoscrotal hypospadias with chordee |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Uncircumcised male patients with penoscrotal hypospadias,
- rudimentary urethral plate
- with moderate-to-severe chordee and
- no history of previous repair
Key exclusion criteria (5 listed)
- circumcised patients,
- patients with other types of hypospadias such as glanular or distal shaft or
- with mild chordee corrected after penile degloving,
- recurrent hypospadias, or
- lost to follow-up.
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 |
|---|---|---|
| Transverse preputial island flap (Duckett's technique) | Procedure or surgery | Transverse preputial island flap (Duckett's technique) |
| Double-faced preputial flap (DFPF) | Procedure or surgery | Double-faced preputial flap (DFPF) |
Primary outcome
Urethrocutaneous fistula (number & percent)
Time frame: 2 years
Urethrocutaneous fistula
Meatal stenosis (number & percent)
Time frame: 2 years
Meatal stenosis
Urethral stricture (number & percent)
Time frame: 3 years
Urethral stricture
5 secondary outcomes
Penile rotation (number & percent)
Time frame: 3 years
Urine stream (in caliber)
Time frame: 3 years
Urine stream (in meters)
Time frame: 3 years
Micturition time (in seconds)
Time frame: 3 years
Follow-up period (in months)
Time frame: 5 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 27 Oct 2020.
- 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
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.
Mohamed M Shahin, MD principal investigator
Al-Azhar New Damietta University
Questions about this trial
What is this clinical trial studying?
A study testing Transverse preputial island flap (Duckett's technique) and Double-faced preputial flap (DFPF) in people with Hypospadias, Penoscrotal and Chordee, run by dr. Muhammad Abdelhafez Mahmoud, MD.
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 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 27 Oct 2020. 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?
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 (number & percent) (time frame: 2 years). 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?
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 27 Oct 2020.