Congenital AnomalyAl-AzharCPCCNCT04636476
One Stage Correction of Congenital Penile Curvature Complex
A study testing Modified Nesbit's procedure and dorsal dartos flap in people with Congenital Anomaly and Chordee, run by dr. Muhammad Abdelhafez Mahmoud, MD at 1 site in Egypt.
Trial summary
To present update \& experience in management of congenital penile curvature complex. Read more about this study
- Who is it for?
- Ages 2 to 10 years, men only
- Conditions the study is for
- Congenital Anomaly, Chordee, Curvature of Penis
- What is being tested?
- Modified Nesbit's procedure and dorsal dartos flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to May 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 2 to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 2 to 10 years old boys
- with congenital curvature complex of the penis
- with normally situated urethral meatus.
- The various degrees of penile curvature ranged between 30° - 90° associated with 30° - 90° penile rotation
Who cannot join
- Boys with CPCC with abnormal urethral meatus as hypospadias or epispadias, or
- with the range of angle degree of penile curvature less than 30° associated with less than 30° penile rotation or
- with acquired penile curvature or
- having an isolated lesion.
Trial locations and contacts
1 site in 1 country.
About this study
To present update \& experience in management of congenital penile curvature complex.
Read the detailed description
Type of study: prospective study
Review of literature:
- Different modalities of urethroplasty for correction of CPCC without hypospadias (Nesbit, modified Nesbit, dorsal dartos flap, combined plication-incision CPI, suture fixation to pubic bone).
- Merits of modified Nesbit technique accompanied by dorsal dartos flap for one-stage correction of CPCC without hypospadias.
This is a prospective study conducted at pediatric surgery department, New Damietta \& Alhoussain Al-Azhar University Hospitals, from January 2015 to May 2020, on 56 male patients with isolated CPCC. All of them will undergo one-stage correction corporoplasty using modified Nesbit technique accompanied by dorsal dartos flap.
Institutes of the study:
A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals at New Damietta \& Cairo. Number of cases: Fifty-six male patients. Time frame: period of 5.6 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 study protocol was approved by local research and ethics committee of Al-Azhar Faculty of Medicine; the study protocol was explained to all guardians and their informed consents were obtained for involvement in the study. Confidentiality and the right to withdraw from the study at any time were guaranteed.
Preoperative preparation:
Children with CPCC those fulfill inclusion criteria will undergo a nursing evaluation of functional health status and a preoperative evaluation by an anesthesiologist \& pediatrician. The angle of penile rotation will be measured on the photograph, using Millen Med DICOM viewer program for image analysis, based on the orientation of the urethral meatus relative to the vertical position.
Follow-up:
Patients will be followed-up at OPD.
Statistical Analysis:
Data will be summarized into continuous variables expressed as mean ± standard deviation and categorical variables expressed as frequency count and percentage (%), using appropriate software computer package. Fisher's exact test is used for comparison of frequency counts/percentage. A two-sided p-value < 0.05 is considered statistically significant.
Discussion:
It will focus on one-stage correction of congenital penile curvature complex (CPCC) using modified Nesbit's procedure (to correct curvature) and dorsal dartos flap (to correct torsion). 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 noticing urine stream direction. At the end, the investigators will conclude that this technique ensures correction of the complex penile anomaly with satisfactory results and nice cosmetic outcome.
- Conditions
- Congenital Anomaly, Chordee, Curvature of Penis, Torsion of the Penis
- Being tested
- Modified Nesbit's procedure and dorsal dartos flap
- Keywords
- Congenital penile curvature;, Penile rotation;, Dorsal dartos flap;, Complex anomaly
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Nesbit's procedure and dorsal dartos flapProcedure or surgery
Modified Nesbit's procedure to correct the penile curvature and dorsal dartos flap to correct the associated penile torsion
| Study group | Role | What they receive |
|---|---|---|
| Modified Nesbit technique followed by dorsal dartos flap | Other | Modified Nesbit technique to correct penile curvature followed by dorsal dartos flap to correct penile torsion Receives: Procedure: Modified Nesbit's procedure and dorsal dartos flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clockwise rotation
Clockwise rotation of the penis (number \& percent)
Measured: 5 years
Counterlockwise rotation
Counterlockwise rotation of the penis (number \& percent)
Measured: 5 years
Ventral Curvature
Ventral Curvature of the penis (number \& percent)
Measured: 5 years
Dorsal Curvature
Dorsal Curvature of the penis (number \& percent)
Measured: 5 years
Lateral Curvature
Lateral Curvature of the penis (number \& percent)
Measured: 5 years
Age
Age of the patients (years)
Measured: 5 years
Operative time
Operative time (minutes)
Measured: 1 day (day of surgery)
Post-operative hospital stay
Hospital stay period (days)
Measured: 1 week
Post-operative follow-up period
Follow-up period (months)
Measured: 5 years
Secondary outcomes (8)
Functional impairment
Functional impairment (number \& percent)
Measured: 5 years
Aesthetic impairment
Aesthetic impairment (number \& percent)
Measured: 5 years
Residual curvature > 10°
Residual curvature > 10° (number \& percent)
Measured: 5 years
Residual rotation > 10°
Residual rotation > 10° (number \& percent)
Measured: 5 years
Post-operative paresthesia
Post-operative paresthesia (number \& percent)
Measured: 5 years
Skin ischemia
Skin ischemia (number \& percent)
Measured: 5 years
Hematoma
Hematoma (number \& percent)
Measured: 5 years
Dressing soaked with blood
Dressing soaked with blood (number \& percent)
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 posted19 Nov 2020
- Study startJan 2015
- Primary completionNov 2019
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital AnomalyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Sequential Assignment Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 56 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,PhD, Principal investigator, Al-Azhar New Damietta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636476
- Sponsor's protocol ID
- Al-AzharCPCC
- Acronym
- Al-AzharCPCC
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- 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 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Stage Correction of Congenital Penile Curvature Complex
- ClinicalTrials.gov ID
- NCT04636476
- Acronym / sponsor ID
- Al-AzharCPCC / Al-AzharCPCC
- Conditions
- Congenital Anomaly, Chordee, Curvature of Penis, Torsion of the Penis
- Keywords
- Congenital penile curvature;, Penile rotation;, Dorsal dartos flap;, Complex anomaly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- dr. Muhammad Abdelhafez Mahmoud, MDUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 19 Nov 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.
To present update \& experience in management of congenital penile curvature complex.
Detailed description
Type of study: prospective study
Review of literature:
- Different modalities of urethroplasty for correction of CPCC without hypospadias (Nesbit, modified Nesbit, dorsal dartos flap, combined plication-incision CPI, suture fixation to pubic bone).
- Merits of modified Nesbit technique accompanied by dorsal dartos flap for one-stage correction of CPCC without hypospadias.
This is a prospective study conducted at pediatric surgery department, New Damietta \& Alhoussain Al-Azhar University Hospitals, from January 2015 to May 2020, on 56 male patients with isolated CPCC. All of them will undergo one-stage correction corporoplasty using modified Nesbit technique accompanied by dorsal dartos flap.
Institutes of the study:
A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals at New Damietta \& Cairo. Number of cases: Fifty-six male patients. Time frame: period of 5.6 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 study protocol was approved by local research and ethics committee of Al-Azhar Faculty of Medicine; the study protocol was explained to all guardians and their informed consents were obtained for involvement in the study. Confidentiality and the right to withdraw from the study at any time were guaranteed.
Preoperative preparation:
Children with CPCC those fulfill inclusion criteria will undergo a nursing evaluation of functional health status and a preoperative evaluation by an anesthesiologist \& pediatrician. The angle of penile rotation will be measured on the photograph, using Millen Med DICOM viewer program for image analysis, based on the orientation of the urethral meatus relative to the vertical position.
Follow-up:
Patients will be followed-up at OPD.
Statistical Analysis:
Data will be summarized into continuous variables expressed as mean ± standard deviation and categorical variables expressed as frequency count and percentage (%), using appropriate software computer package. Fisher's exact test is used for comparison of frequency counts/percentage. A two-sided p-value < 0.05 is considered statistically significant.
Discussion:
It will focus on one-stage correction of congenital penile curvature complex (CPCC) using modified Nesbit's procedure (to correct curvature) and dorsal dartos flap (to correct torsion). 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 noticing urine stream direction. At the end, the investigators will conclude that this technique ensures correction of the complex penile anomaly with satisfactory results and nice cosmetic outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential Assignment Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Modified Nesbit technique followed by dorsal dartos flap | Other | Procedure: Modified Nesbit's procedure and dorsal dartos flapModified Nesbit technique to correct penile curvature followed by dorsal dartos flap to correct penile torsion |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 2 to 10 years old boys
- with congenital curvature complex of the penis
- with normally situated urethral meatus.
- The various degrees of penile curvature ranged between 30° - 90° associated with 30° - 90° penile rotation
Key exclusion criteria (4 listed)
- Boys with CPCC with abnormal urethral meatus as hypospadias or epispadias, or
- with the range of angle degree of penile curvature less than 30° associated with less than 30° penile rotation or
- with acquired penile curvature or
- having an isolated lesion.
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 |
|---|---|---|
| Modified Nesbit's procedure and dorsal dartos flapModified Nesbit's procedure to correct the penile curvature and dorsal dartos flap to correct the associated penile torsion | Procedure or surgery | Modified Nesbit technique followed by dorsal dartos flap |
Primary outcome
Clockwise rotation
Time frame: 5 years
Clockwise rotation of the penis (number \& percent)
Counterlockwise rotation
Time frame: 5 years
Counterlockwise rotation of the penis (number \& percent)
Ventral Curvature
Time frame: 5 years
Ventral Curvature of the penis (number \& percent)
Dorsal Curvature
Time frame: 5 years
Dorsal Curvature of the penis (number \& percent)
Lateral Curvature
Time frame: 5 years
Lateral Curvature of the penis (number \& percent)
Age
Time frame: 5 years
Age of the patients (years)
Operative time
Time frame: 1 day (day of surgery)
Operative time (minutes)
Post-operative hospital stay
Time frame: 1 week
Hospital stay period (days)
Post-operative follow-up period
Time frame: 5 years
Follow-up period (months)
8 secondary outcomes
Functional impairment
Time frame: 5 years
Aesthetic impairment
Time frame: 5 years
Residual curvature > 10°
Time frame: 5 years
Residual rotation > 10°
Time frame: 5 years
Post-operative paresthesia
Time frame: 5 years
Skin ischemia
Time frame: 5 years
Hematoma
Time frame: 5 years
Dressing soaked with blood
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 19 Nov 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
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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.
Mohamed M Shahin, MD,PhD principal investigator
Al-Azhar New Damietta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Nesbit's procedure and dorsal dartos flap in people with Congenital Anomaly and Chordee, 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 4 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: finished, as of the sponsor's last update on 19 Nov 2020. 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?
Clockwise rotation (time frame: 5 years). The study lists 9 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 Nov 2020.