Hypospadias Clinical Trials

Hypospadias is one of the most common congenital urogenital anomalies in males, occurring in approximately 1 in every 200-300 male births. It is characterized by abnormal positioning of the urethral meatus on the ventral surface of the penis. Surgical repair is the standard treatment; however, urethrocutaneous fistula formation remains one of the most frequent and clinically significant postoperative complications, potentially requiring reoperation and causing considerable distress to both the patient and the family. Caudal nerve block is a widely used regional anesthesia technique in pediatric lower abdominal and genitourinary surgery, valued for its high analgesic efficacy, relative ease of application, and low complication profile. However, emerging evidence suggests that caudal block may be associated with an increased incidence of postoperative complications following hypospadias repair, including fistula formation and wound edema. Notably, Kundra et al. (2012) reported a fistula rate of 19.2% in patients who received caudal block, compared to 0% in those who received penile block, raising important questions about the routine use of caudal block in hypospadias surgery. This prospective, multicenter, randomized controlled trial aims to evaluate the effect of caudal block on the incidence of urethrocutaneous fistula following distal hypospadias repair. A total of 80 male patients aged 6-60 months will be randomized 1:1 to either receive general anesthesia with caudal block or general anesthesia alone. The primary outcome is the incidence of urethrocutaneous fistula. Secondary outcomes include perioperative opioid consumption, postoperative pain scores, analgesic duration, and other surgical complications such as wound dehiscence and urethral stricture. Patients will be followed up for 3-6 months postoperatively. The study will be conducted across four centers in Turkey. Results are expected to provide evidence-based guidance on the role of caudal block in pediatric hypospadias repair.