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Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair

NCT07675798 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-06-30

No results posted yet for this study

Summary

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 repair, including fistula formation and wound edema. Notably, Kundra et al. (2012) reported a fistula rate of 19.2% in patients who received caudal block, compared to 0% in those who received penile block, raising important questions about the routine use of caudal block in hypospadias surgery.

This prospective, multicenter, randomized controlled trial aims to evaluate the effect of caudal block on the incidence of urethrocutaneous fistula following distal hypospadias repair. A total of 80 male patients aged 6-60 months will be randomized 1:1 to either receive general anesthesia with caudal block or general anesthesia alone. The primary outcome is the incidence of urethrocutaneous fistula. Secondary outcomes include perioperative opioid consumption, postoperative pain scores, analgesic duration, and other surgical complications such as wound dehiscence and urethral stricture. Patients will be followed up for 3-6 months postoperatively. The study will be conducted across four centers in Turkey. Results are expected to provide evidence-based guidance on the role of caudal block in pediatric hypospadias repair.

Conditions

  • Hypospadias
  • Caudal Block
  • Pediatric Anesthesia

Interventions

PROCEDURE

Caudal Block

General anesthesia combined with caudal block administered prior to distal hypospadias repair. Caudal block is performed using bupivacaine hydrochloride as part of standard institutional analgesic protocol.

PROCEDURE

General Anesthesia without Caudal Block

General anesthesia alone administered without caudal block for distal hypospadias repair. Intravenous analgesic agents used as per standard institutional protocol.

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
60 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-08-01
Completion
2026-08-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675798 on ClinicalTrials.gov