NCT07675798 Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair
| NCT ID | NCT07675798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital |
| Condition | Hypospadias |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-12-01 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Male patients aged 6-60 months * Diagnosed with distal hypospadias * Scheduled for elective hypospadias repair * Written informed consent obtained from parent or legal guardian Exclusion Criteria: * Age \< 6 months or \> 60 months * Proximal or non-distal hypospadias * Previous hypospadias repair * Skin lesions at the epidural/caudal injection site * Coagulopathy * Known allergy to anesthetic agents, particularly bupivacaine hydrochloride * Spinal anomalies * Chronic granulomatous disease * Diabetes mellitus * Patients receiving corticosteroid therapy * Refusal of informed consent by parent or guardian
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07675798 clinical trial?
This trial is open to male participants only, aged 6 Months or older, up to 60 Months, studying Hypospadias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07675798 currently recruiting?
Yes, NCT07675798 is actively recruiting participants. Contact the research team at fikretsalik@gmail.com for enrollment information.
Where is the NCT07675798 trial being conducted?
This trial is being conducted at Diyarbakır, Turkey (Türkiye), Diyarbakır, Turkey (Türkiye).
Who is sponsoring the NCT07675798 clinical trial?
NCT07675798 is sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. The trial plans to enroll 80 participants.