Actively Recruiting
Caudal Anesthesia Versus Local Anesthesia in Hypospadias
Led by Necmi Kadıoğlu Hospital · Updated on 2024-08-20
200
Participants Needed
3
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hypospadias is among the most common congenital genital malformations in boys and is typically treated through surgical intervention. During pediatric urological surgery, caudal anesthesia, also known as a caudal block, is frequently employed as a regional anesthetic technique. It has proven to be a safe and effective anesthetic approach in children, with a low rate of anesthesia-related complications. However, despite the low incidence of complications directly associated with the caudal block, there is limited and inconclusive evidence regarding its impact on surgical complications. Therefore, this randomized controlled superiority trial aims to evaluate whether the use of caudal anesthesia, compared to the dorsal penile block, is associated with an increased incidence of urethrocutaneous fistulas and glans dehiscence following hypospadias repair.
CONDITIONS
Official Title
Caudal Anesthesia Versus Local Anesthesia in Hypospadias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 6 and 48 months
- Diagnosed with distal hypospadias
- Consent to participate in the study
You will not qualify if you...
- Midpenile hypospadias
- Proximal hypospadias
- Previous hypospadias surgery
- Existing conditions such as diabetes, hypertension, or heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Ss. Cyril and Methodius University in Skopje, Pediatric Surgery, Skopje, Macedonia, the former Yugoslav Republic of North Macedonia
Skopje, North Macedonia
Actively Recruiting
2
Ao Gk Medsi
Moscow, Russia
Actively Recruiting
3
Necmi Kadioglu Esenyurt State Hospital
Istanbul, Turkey (Türkiye), 34430
Actively Recruiting
Research Team
M
Mustafa Azizoğlu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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