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Distal Hypospadias Repair Outcome

A

Armia Ezzat Thabet Azer

Status

Begins enrollment this month

Conditions

Distal Penile Hypospadias (Disorder)

Treatments

Procedure: Distal Penile Hypospadias (Disorder)

Study type

Interventional

Funder types

Other

Identifiers

NCT06700629
DPH repair outcome

Details and patient eligibility

About

Aim is : To define the preoperative parameters that may influence the results of distal hypospadias repair

Full description

Hypospadias is a congenital deformity where the opening of the urethra (the meatus) is sited on the underside (ventral) part of the penis, anywhere from the glans to the perineum.

It occurs in 1 in 250 live male births. it is often associated with "hooded" foreskin and chordee (ventral curvature of the penis shaft).

Hypospadias can be classified according to the anatomical location of meatus:

Distal-anterior hypospadias (located on the glans or distal shaft of the penis and the most common type of hypospadias) Intermediate-middle (penile). Proximal-posterior (penoscrotal, scrotal, perineal).

Diagnosis includes a description of the local findings:

Position, shape and width of the orifice Presence of atretic urethra and division of corpus spongiosum Appearance of the preputial hood and scrotum Size of the penis Curvature of the penis on erection. Aim of hypospadias surgery :(2) Is to correct penile curvature,to form neo-urethera of an adequate size, to bring the neomeatus to the tip of glans, and offer satisfactory cosmetic results.

The ideal age at surgery for primary hypospadias repair is usually 6-18 months. The complication rate is about 10% in distal hypospadias repair.

Complications include:

  1. uretherocutaneous fistula.
  2. meatal stenosis.
  3. urethral stricture.
  4. Urethral diverticulum. After hypospadias repairs, long-term follow-up is necessary, up to adolescence, to detect urethral stricture, voiding dysfunction and recurrent penile curvature.

Enrollment

50 estimated patients

Sex

Male

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Child with distal hypospadias, uncircumcised , without meatal stenosis and no previous surgery for hypospadias

Exclusion criteria

  • Any surgical manipulation includes circumcision or meatotomy. Patient refusal to be enrolled in the research. Patient lost follow up in the first six months

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

DPH repair outcome
Other group
Description:
Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...): A. Preoperative preparation: All patients will be subjected to evaluation including: 1. Measurement of penile length and width (in cm). 2. The shape of glans. (clefted , incomplete ceft, flat) 3. Glans size is measured by cubic centimetres. 4. Presence or absence of chordee and its degree. 5. Urethral plate condition and it's length, width and surface area. 6. Condition of skin over the urethra. 7. Presence of penile torsion. All patients should undergo preoperative surgical fitness including; complete blood picture, prothrombin time, concentration and INR, ECG and renal function test. Prophylactic systemic antibiotics are given intraoperatively.
Treatment:
Procedure: Distal Penile Hypospadias (Disorder)

Trial contacts and locations

2

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Central trial contact

Armia Ezzat Thabet Azer, bachelor degree

Data sourced from clinicaltrials.gov

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