Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair

NCT07675798 | Recruiting

• 1 other identifier: 357/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Urethrocutaneous Fistula

  Development of urethrocutaneous fistula following distal hypospadias repair, assessed by clinical examination

  up to 3 months

Secondary Outcomes (4)

• Postoperative Pain Scores

  Up to 24 hours postoperatively

• Surgical Complications

  Up to 3 months

• Duration of Effective Analgesia

  Up to 24 hours postoperatively

• Total Consumption of Rescue Analgesics

  Up to 24 hours postoperatively

Study Arms (2)

Group 1) Caudal Block Group

EXPERIMENTAL

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: Caudal Block

Group 2) Non-Caudal Group

ACTIVE COMPARATOR

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

Procedure: General Anesthesia without Caudal Block

Interventions

Caudal Block PROCEDURE

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.

Group 1) Caudal Block Group

General Anesthesia without Caudal Block PROCEDURE

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

Group 2) Non-Caudal Group

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male patients aged 6-60 months
• Diagnosed with distal hypospadias
• Scheduled for elective hypospadias repair
• Written informed consent obtained from parent or legal guardian

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (2)

Dicle University

Diyarbakır, Eyalet/Yerleşke, 21070, Turkey (Türkiye)

RECRUITING

Gazi Yaşargil Training and Research Hospital

Diyarbakır, Eyalet/Yerleşke, 21070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypospadias

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Fikret Salık, associate professor

CONTACT

+905076214125; fikretsalik@gmail.com

Fikret Salık

CONTACT

05076214125; fikretsalik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicine Doctor Associate Professor in Anesthesiology

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 30, 2026
• Study Start: December 1, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

TU (2)