Clinical trial NCT06700629: Distal Hypospadias Repair Outcome
Official title: Preoperative Predictors of Distal Hypospadias Repair Outcome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Distal Penile Hypospadias (Disorder)
Keywords: Penile Hypospadias
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 50
Sex: MALE
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional outcome of Distal Penile Hypospadias Repair
timeFrame: Six months postoperatively
Secondary outcomes:
measure: Cosmetic outcome of Distal Penile Hypospadias Repair
timeFrame: Six months postoperatively
measure: Complication Rate Following Distal Hypospadias Repair
timeFrame: Weekly assessments during the first month and monthly assessments for the following five months postoperatively.
measure: Patient-Reported Outcomes
timeFrame: Six months postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Noha Elabody
city: Assiut
country: Egypt
facility: Faculty Of Medicine Assiut University
Study officials:
References:
citation: 1) Belman AB. Hypospadias and chordee. In: Belman AB, King LR, Kramer SA, eds. Clinical Pediatric Urology. 4th edn. London, Martin Dunitz, 2002, pp. 1061-1092. 2) Mouriquand OD, Mure PY. Hypospadias. In: Gearhart J, Rink R, Mouriquand PDE, eds. Pediatric Urology, Philadelphia, WB Saunders, 2001, pp. 713-728. 3) Snodgrass W (1994) Tubularized, incised plate urethroplasty for distal hypospadias 151: 464-465. 4) Duckett JW Jr, Kaplan GW, Woodard JR, Devine CJ Jr (1980) Panel: complications of hypospadias repair 7: 443-454. 5) Braga LHP, Lorenzo AJ, Pippi Salle JL. Tubularized incised plate urethroplasty for distal hypospadias: A literature review. Indian J Urol 2008 Apr; 24(2)219-25. 6) Allen TD,Spence HM: The Surgical Treatment Of Coronal hypospadias and related problems , J. Urol 100:504, 1968. 7) Holland AJA, Smith GHH, Ross Fl, et al. HOSE: an objective scoring system for evaluating the results of hypospadias surgery. BJU Int 2001;88:255-8. 8) Hinman F. Penis: Plastic operation. In: Atlas of urologic surgery 2nd ed. Philadelphia; WB Saunders, 1998:96-157. 9) Abdul-Ghafoor B, Al-Dabbagh H. Primary distal hypospadias repair: tubularized incised plate urethroplasty (Snodgrass) versus the perimeatal based flap (Mathieu). Iraqi J Com Med 2009; 23-1. Rabnowitz R. and Hulbert W.C: Meatal-based flap Mathieu procedure. Adult and Pediatric. Saunders, Philadelphia, pp 39-43, 1999