NCT05742529

Cosmotic Outcome of Distal Penile Hypospidias Repair Using Stitch by Stitch Glanuloplasty Versus TIP

Completed NA Last updated 24 February 2023

What this trial tests

NA trial testing TIP in Distal Penile Hypospadias in 40 participants. Completed in 1 March 2022.

Timeline

1 March 2020

Primary endpoint
1 March 2021

1 March 2022

Quick facts

Lead sponsor	Sohag University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 March 2020
Primary completion	1 March 2021
Estimated completion	1 March 2022
Sites	1 location across Egypt

Drugs / interventions tested

• TIP — full drug profile →
• STITCH BY STITCH

Conditions studied

• Distal Penile Hypospadias — all drugs for Distal Penile Hypospadias →

Sponsor

Sohag University

Who can join

Adults 1 to 3, male only, with Distal Penile Hypospadias. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hypospadias is generally defined as the combination of three anatomic anomalies of penis, which are an abnormal ventral opening of the urethral orifice, ventral curvature of the penis, and abnormal distribution of the foreskin around the glans with a ventrally deficient hooded foreskin . It is estimated that about 1 in every 200 babies is born with hypospadias in the United States, making it one of the most common birth defects.

In newborn males, hypospadias is the second most common congenital anomaly after undescended testis. Due to incomplete closure of the penile structures during embryogenesis, the urethral opening is displaced along the ventral side of the penis . Most hypospadias occur as an isolated condition, but associated anomalies include uni/bilateral cryptorchidism and micropenis .

Duckett proposed the most commonly used classification; i.e., nearly 70% of hypospadias are either glanular or distally located on the penis and are considered a mild form, whereas the remainder is more severe and complex The main goal for hypospadias repair is to achieve both cosmetic and functional normality. Reasons for treating hypospadias include spraying of urinary stream, inability to urinate in standing position, curvature leading to difficulties during intercourse, fertility issues because of difficulty with sperm deposition, and decreased satisfaction with genital appearance. Current guidelines consider optimal age for hypospadias repair somewhere between 6 and 18 months, depending on the severity and the need for multiple procedures .

Penile biometrical parameters, like a small glans width and narrow urethral plate, are some of the anatomical factors associated with increased postoperative complications and form a technical challenge . Functional outcome was considered satisfactory when the patient could micturate an ideal stream of urine (single, compact, rifled, non-dispersed urinary stream of adequate caliber) without straining. Cosmetic outcome was considered satisfactory when a straight penis was obtained with a vertical slit like, wide, smooth external meatus at the tip of a conical glans .

The normal meatus is a vertical slit with smooth and sharp edges that is centrally located within the glans penis . The literature lacks standardization of techniques for hypospadias repair and uniform definitions of complications and outcome assessment .

Many surgical techniques have been described for glans closure and meatoplasty with variable outcomes, but none of them fits all patients with hypospadias; each procedure has its limitations and demands specific selection criteria.

Duckett described the "meatal advancement and glanuloplasty incorporated" (MAGPI) procedure. The two essential elements of MAGPI are meatoplasty and glanuloplasty. However, many researchers reported a high incidence of partial meatal regression in their patients following the MAGPI procedure.

In 1928, Mathieu described a single-stage, meatal based flap technique to repair the distal forms of hypospadias but results in flat meatus. In 2000 Boddy and Samuel reported the "V-incision" sutured MAVIS technique to provide a cosmetically acceptable natural slit-like meatus in Mathieu cases Rich et al. in 1989 described a urethral plate incision (hinging) as a modification of the Mathieu repair to improve the cosmetic outcome of the neo-meatus. It helps in achieving a slit-like vertical meatus. Nevertheless, a healthy wide urethral plate with no scarring is essential for a successful outcome Snodgrass extended the concept of urethral plate hinging by incising the whole urethral plate in the midline from the hypospadias meatus distally. It helps in the tabularization of the plate with a good cosmetic outcome.

-stitch by stitch technique: Operative technique :starts with penile degloving, preparation of the flap (Site of hypospadic meatus is determined after degloving). Creation of a narrow strip of the urethral plate with wide glanular wings is done using bilateral incisions which are extended to the tip of the glans. The width of the urethral plate is about 3 mm then we suture the flap to the narrow urethral plate in two layers in continuous manner using vicryl 6/0 over a suitable plastic catheter. Triangular (Vshape) area of the distal part of the flap is excised a the midline. After this we anastomose the flap to thetip of the glans. The glans appears opened in the midline as inverted V shape. Closure of the glans is finished in the midline using three mattress interrupted sutures with another three simple stitches are used in between

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.