CompletedHypospadiasNCT05660564
Preputial Graft Urethroplasty in Primary Repair of Hypospadias
An observational study of Completed, run by Sarah Magdy Abdelmohsen at 1 site in Egypt.
Trial summary
Introduction: Hypospadias repair is debated. There has been no perfect procedure until this moment. A graft is sometimes needed to fundamentally strengthen the narrow urethral plate. Read more about this study
- Who is it for?
- Ages 6 months to 8 years
- Conditions the study is for
- Completed
- What is being tested?
- DIGU Dorsal inlay preputial graft urethroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 30 Oct 2019
- Phase
- Observational
- 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 8 years
- All sexes
- Child
Study population: The study included hypospadias patients who were admitted to a hypospadias clinic at a university hospital.
Who may be able to join
- Inclusion criteria were that a child complained of primary distal or mid-penile hypospadias at age 6 months or more, had a urethral plate less than 8 mm, and had a non-circumcised penis.
Who cannot join
- . Children with redo hypospadias, significant Chordee (30 percent or more), non-preservable plates, circumcised patients, and proximal hypospadias were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aswan University Hospital
Introduction: Hypospadias repair is debated. There has been no perfect procedure until this moment. A graft is sometimes needed to fundamentally strengthen the narrow urethral plate.
Patients and methods: The study included a child who had primary distal or mid-penile hypospadias at the age of 6 months or more, a urethral plate less than 8 mm in a non-circumcised penis, and was operated on using the Snodgraft technique.
Read the detailed description
Patients and methods This study was designed as a prospective cross-sectional study during the period from May 2018 to October 2019. The study included hypospadias patients who were admitted to a hypospadias clinic at a university hospital.
Inclusion criteria were that a child complained of primary distal or mid-penile hypospadias at age 6 months or more, had a urethral plate less than 8 mm, and had a non-circumcised penis. Children with redo hypospadias, significant Chordee (30 percent or more), non-preservable plates, circumcised patients, and proximal hypospadias were excluded.
History has been taken from the parent of the patient in the form of the direction of the urine stream, manifestation of urinary tract infection, past history and previous repair, family history of hypospadias among first-degree relatives, history of hormonal intake (local or systemic), gestational history as a history of acute or chronic diseases, and exposure to drugs or environmental endocrinological disrupters.
Physical examination as body weight, other associated congenital anomalies, and other medical problems. Local examination of the external genitalia includes the penile size and length (normal or small penis). The meatus was examined for its position, caliber, and presence or absence of surrounding shiny skin. The prepuce was examined for shape and width (complete or incomplete). The shape and width of the glens were examined (cleft, incomplete cleft, flat). The urethral plate was examined for its width, length, or associated urethral dysplasia. If and to what extent there is or is not penile curvature, scrotal transposition, or penile rotation, Examination of the scrotal wall is either well developed or underdeveloped. Examination of the scrotal contents: palpation of the testis, whether it is present or absent (undescended), its site, size, bilateral symmetry, or any associated problem such as a congenital hernia or hydrocele.
Routine investigations such as CBCS, PT, PC, urine analysis, and urine culture if necessary. Abdominopelvic ultrasonography to rule out associated congenital anomalies. Before general anesthesia was administered, all patients received a preoperative dose of IV 3rd generation cephalosporins (50 mg/kg). Then the caudal block was done to reduce the post-operative pain. Patients are placed in a supine position, and sterilization and toweling are done to expose the external genitalia.
Preoperative measurements were taken after induction of anesthesia before the start of the operation; penile girth, urethral plate length, urethral plate width, vertical length of the glans (Fig. 2A), and maximum width of the glans .
- Conditions
- Completed
- Being tested
- DIGU Dorsal inlay preputial graft urethroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIGU Dorsal inlay preputial graft urethroplastyProcedure or surgery
Using a scalpel, a midline incision is made from the meatus to the end of the plate .
The edge of the distal glans should not be incised to avoid meatal stenosis. The depth of this relaxing incision depends on the plate's width and depth, but in all cases, it extends down to the corpora cavernosa. Degloving of the penile skin to the penoscrotal junction If a minimal chord is present, it should be corrected.
From the inner prepuce, a free graft was measured, harvested, defatted, and stitched to the UP. With interrupted 6/0 polyglactin sutures running from the old meatus to the tip of the glans, the graft was secured to the medial edges of the incised plate. Depending on the location of the meatus, the characteristics of the UP, and the depth of the midline incision, the graft width and length varied in each case.
What is being measured
The primary outcome is the main question the study is designed to answer.
75% success rate
Measured: one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 May 2018
- Primary completion1 May 2018
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CompletedStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Magdy Abdelmohsen
- Sponsor type
- University, hospital or other
- Collaborators
- Aswan University Hospital
- Responsible party
- Sponsor-investigator, Sarah Magdy Abdelmohsen, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660564
- Sponsor's protocol ID
- AswanUH5
- Acronym
- Hypospadias
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aswan University Hospital
- ClinicalTrials.gov ID
- NCT05660564
- Acronym / sponsor ID
- Hypospadias / AswanUH5
- Conditions
- Completed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sarah Magdy AbdelmohsenUniversity, hospital or other
- Collaborators
- Aswan University Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 21 Dec 2022 (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.
Introduction: Hypospadias repair is debated. There has been no perfect procedure until this moment. A graft is sometimes needed to fundamentally strengthen the narrow urethral plate.
Patients and methods: The study included a child who had primary distal or mid-penile hypospadias at the age of 6 months or more, a urethral plate less than 8 mm in a non-circumcised penis, and was operated on using the Snodgraft technique.
Detailed description
Patients and methods This study was designed as a prospective cross-sectional study during the period from May 2018 to October 2019. The study included hypospadias patients who were admitted to a hypospadias clinic at a university hospital.
Inclusion criteria were that a child complained of primary distal or mid-penile hypospadias at age 6 months or more, had a urethral plate less than 8 mm, and had a non-circumcised penis. Children with redo hypospadias, significant Chordee (30 percent or more), non-preservable plates, circumcised patients, and proximal hypospadias were excluded.
History has been taken from the parent of the patient in the form of the direction of the urine stream, manifestation of urinary tract infection, past history and previous repair, family history of hypospadias among first-degree relatives, history of hormonal intake (local or systemic), gestational history as a history of acute or chronic diseases, and exposure to drugs or environmental endocrinological disrupters.
Physical examination as body weight, other associated congenital anomalies, and other medical problems. Local examination of the external genitalia includes the penile size and length (normal or small penis). The meatus was examined for its position, caliber, and presence or absence of surrounding shiny skin. The prepuce was examined for shape and width (complete or incomplete). The shape and width of the glens were examined (cleft, incomplete cleft, flat). The urethral plate was examined for its width, length, or associated urethral dysplasia. If and to what extent there is or is not penile curvature, scrotal transposition, or penile rotation, Examination of the scrotal wall is either well developed or underdeveloped. Examination of the scrotal contents: palpation of the testis, whether it is present or absent (undescended), its site, size, bilateral symmetry, or any associated problem such as a congenital hernia or hydrocele.
Routine investigations such as CBCS, PT, PC, urine analysis, and urine culture if necessary. Abdominopelvic ultrasonography to rule out associated congenital anomalies. Before general anesthesia was administered, all patients received a preoperative dose of IV 3rd generation cephalosporins (50 mg/kg). Then the caudal block was done to reduce the post-operative pain. Patients are placed in a supine position, and sterilization and toweling are done to expose the external genitalia.
Preoperative measurements were taken after induction of anesthesia before the start of the operation; penile girth, urethral plate length, urethral plate width, vertical length of the glans (Fig. 2A), and maximum width of the glans .
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- The study included hypospadias patients who were admitted to a hypospadias clinic at a university hospital.
Key inclusion criteria (1 listed)
- Inclusion criteria were that a child complained of primary distal or mid-penile hypospadias at age 6 months or more, had a urethral plate less than 8 mm, and had a non-circumcised penis.
Key exclusion criteria (1 listed)
- . Children with redo hypospadias, significant Chordee (30 percent or more), non-preservable plates, circumcised patients, and proximal hypospadias were excluded.
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 |
|---|---|---|
| DIGU Dorsal inlay preputial graft urethroplastyUsing a scalpel, a midline incision is made from the meatus to the end of the plate . The edge of the distal glans should not be incised to avoid meatal stenosis. The depth of this relaxing incision depends on the plate's width and depth, but in all cases, it extends down to the corpora cavernosa. Degloving of the penile skin to the penoscrotal junction If a minimal chord is present, it should be corrected. From the inner prepuce, a free graft was measured, harvested, defatted, and stitched to the UP. With interrupted 6/0 polyglactin sutures running from the old meatus to the tip of the glans, the graft was secured to the medial edges of the incised plate. Depending on the location of the meatus, the characteristics of the UP, and the depth of the midline incision, the graft width and length varied in each case. | Procedure or surgery | – |
Primary outcome
75% success rate
Time frame: one and half year
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 21 Dec 2022.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Completed, run by Sarah Magdy Abdelmohsen 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 21 Dec 2022. 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?
75% success rate (time frame: one and half year). 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 21 Dec 2022.