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Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair

RecruitingNAAges 6 Months - 60 MonthsMaleSaglik Bilimleri Universitesi Gazi Yasargil Train…
NCT07675798 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 r

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📋 Eligibility rules (as published)
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
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What it tests

  • Caudal Block
  • General Anesthesia without Caudal Block
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Where

2 sites
Dicle University
Diyarbakır, Turkey (Türkiye)
Gazi Yaşargil Training and Research Hospital
Diyarbakır, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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