About this trial

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.

Eligibility criteria

Qualifiers

Aged between 6 and 48 months

Distal hypospadias

Acceptance of participation

Disqualifiers

Midpenil hypospadias

Proximal hypospadias

Prior surgery

Comorbidity (diabetes, hypertention, cardiac pathology)

Trial design

Treatments tested in this trial

  • Caudal block anesthesia
  • Dorsal penile block anesthesia

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

3
North Macedonia
Ss. Cyril and Methodius University in Skopje, Pediatric Surgery, Skopje, Macedonia, the former Yugoslav Republic of North Macedonia Skopje North Macedonia
Russia
Ao Gk Medsi Moscow Russia
Turkey (Türkiye)
Necmi Kadioglu Esenyurt State Hospital34430, Istanbul Turkey (Türkiye)

Sponsors and collaborators

Necmi Kadıoğlu Hospital

Lead sponsor