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CompletedNCT05660564HypospadiasUpdated Dec 21, 2022

Preputial Graft Urethroplasty in Primary Repair of Hypospadias

An observational study in Completed, sponsored by Sarah Magdy Abdelmohsen. Completed at 1 site in Egypt. Open to participants aged 6 Months to 8 Years. Per ClinicalTrials.gov, last updated 2022-12-21.

Sponsored by Sarah Magdy Abdelmohsen · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
40
Ages
6 Months to 8 Years
Sex
All
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Study 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.

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 .

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Conditions studied

  • Completed
03

In context

Lead sponsor

Sarah Magdy Abdelmohsen is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 8 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study included hypospadias patients who were admitted to a hypospadias clinic at a university hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • . Children with redo hypospadias, significant Chordee (30 percent or more), non-preservable plates, circumcised patients, and proximal hypospadias were excluded.
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Interventions

  • ProcedureDIGU Dorsal inlay preputial graft urethroplasty

    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.

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What researchers measure

Primary outcomes

  1. 75% success rate

    Time frame: one and half year

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Study locations

1 site
  • Sarah Magdy Abdelmohsen
    Cairo, 11331, Egypt
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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in May 2018, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2022
First posted
Dec 21, 2022
StartActual
May 1, 2018
Primary completionActual
May 1, 2018
CompletionActual
Oct 30, 2019
Last update
Dec 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05660564
Lead sponsor
Sarah Magdy Abdelmohsen
Collaborators
Aswan University Hospital
Responsible party
Sarah Magdy Abdelmohsen (Lecturer, Aswan University Hospital) — Sponsor-investigator
First posted
Dec 21, 2022
Start date
May 1, 2018
Primary completion
May 1, 2018
Completion
Oct 30, 2019
Last update
Dec 21, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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