This study compares two surgical techniques used to repair distal hypospadias in children: topography-guided repair (TGR), a newer approach, and tubularized incised plate (TIP) repair, a commonly used standard technique. Children with distal hypospadias were randomly assigned to receive one of the two procedures. Researchers assessed early surgical complications, need for additional surgery, and postoperative appearance and function during follow-up visits over 12 months. The study aims to determine whether TGR can be safely adopted by surgical teams other than its developer and to guide larger future studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
101
Topography-guided repair is a surgical procedure for primary distal penile hypospadias. The repair involves identification and mobilization of the spongiosal pillars, excision of the ventral hypoplastic urothelial sheet, approximation of the spongiosal tissue over a silicone catheter, and subcuticular closure of the glanular wings. An 8-Fr silicone catheter is maintained for 7 days after surgery.
Tubularized incised plate repair is a surgical procedure for primary distal penile hypospadias. The urethral plate is incised in the midline and tubularized to create a neourethra, followed by glans closure using 6-0 polyglactin sutures. An 8-Fr silicone catheter is maintained for 7 days after surgery. Postoperative dressing and wound-care protocols are the same as in the topography-guided repair group.
Alexandria Faculty of Medicine
Alexandria, Egypt
Complication-Free Rate
The proportion of participants without postoperative complications, including urethrocutaneous fistula, meatal stenosis, glanular dehiscence, or other complications, at 3 months after the primary repair. Participants were classified according to their current complication status before any revision surgery.
Time frame: 3 months after primary hypospadias repair
Complication-Free Rate at 12 Months
The proportion of participants without unresolved postoperative complications at 12 months after primary repair. Participants who had a complication that was successfully revised were classified as complication-free; participants with unresolved complications or pending revision were classified as complicated.
Time frame: 12 months after primary hypospadias repair
Hypospadias Objective Scoring Evaluation (HOSE) Score
HOSE is an examiner-scored assessment of postoperative hypospadias repair outcome. Scores range from 5 to 16, with scores of 14 or higher considered an acceptable outcome.
Time frame: 3 and 12 months after primary hypospadias repair
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