NCT06417060 Caudal Anesthesia Versus Local Anesthesia in Hypospadias
| NCT ID | NCT06417060 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Necmi Kadıoğlu Hospital |
| Condition | Hypospadias |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-05-25 |
| Primary Completion | 2024-08-29 |
Eligibility & Interventions
Eligibility Fast-Check
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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 200 participants in total. It began in 2023-05-25 with a primary completion date of 2024-08-29.
⚠ 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 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
Inclusion Criteria: * Aged between 6 and 48 months * Distal hypospadias * Acceptance of participation Exclusion Criteria: * Midpenil hypospadias * Proximal hypospadias * Prior surgery * Comorbidity (diabetes, hypertention, cardiac pathology)
Contact & Investigator
Mustafa Azizoğlu
PRINCIPAL INVESTIGATOR
Necmi Kadıoğlu State Hospital
Frequently Asked Questions
Who can join the NCT06417060 clinical trial?
This trial is open to male participants only, aged 6 Months or older, up to 48 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 NCT06417060 currently recruiting?
Yes, NCT06417060 is actively recruiting participants. Contact the research team at mdmazizoglu@gmail.com for enrollment information.
Where is the NCT06417060 trial being conducted?
This trial is being conducted at Skopje, North Macedonia, Moscow, Russia, Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06417060 clinical trial?
NCT06417060 is sponsored by Necmi Kadıoğlu Hospital. The principal investigator is Mustafa Azizoğlu at Necmi Kadıoğlu State Hospital. The trial plans to enroll 200 participants.