Caudal Block for Distal Hypospadias Repair in Young Boys

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter randomized trial enrolling 80 male children aged 6 to 60 months undergoing distal hypospadias repair. Participants are randomized 1:1 to receive caudal block with general anesthesia or general anesthesia alone, with outcomes including fistula formation, wound healing, pain scores, analgesic use, and length of stay tracked for 3–6 months postoperatively. Data on demographics, surgical details, and complications will be collected and analyzed using standard statistical tests. The study aims to clarify whether caudal anesthesia influences postoperative complications in this surgical population. It is conducted across four centers with centralized data analysis.

Why it matters

Who can join: the full rules

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

Where it's running

• Dicle University
  Diyarbakır, Eyalet/Yerleşke, Turkey (Türkiye) Recruiting
• Gazi Yaşargil Training and Research Hospital
  Diyarbakır, Eyalet/Yerleşke, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Fikret Salık, associate professor
• Email: fikretsalik@gmail.com
• Phone: +905076214125

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.