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Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair

23 juni 2026 uppdaterad av: Fikret Salık, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

The Effect of Caudal Block on the İncidence of Urethrocutaneous Fistula After Distal Hypospadias Repair: A Multicentre, Randomized Controlled Trial

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a prospective, multicenter, randomized controlled trial. Eighty male patients aged 6-60 months undergoing distal hypospadias repair will be enrolled across four centers: Dicle University Faculty of Medicine Hospital, Istanbul Başakşehir Çam ve Sakura City Hospital, Diyarbakır Gazi Yaşargil Training and Research Hospital, and Mardin Training and Research Hospital. Patients will be randomized 1:1 using a simple randomization method with sealed envelope allocation into two groups: Group 1 (caudal block + general anesthesia) and Group 2 (general anesthesia alone). Demographic and clinical data, anesthesia and surgery duration, intraoperative and postoperative analgesic use, pain scores, length of hospital stay, and postoperative complications will be recorded. Patients will be followed for 3-6 months postoperatively for fistula formation, wound dehiscence, and urethral stricture. Statistical analysis will be performed using SPSS v22.0; Student t-test, Mann-Whitney U test, Kruskal-Wallis test, and chi-square test will be applied as appropriate. A p value ≤ 0.05 will be considered statistically significant.

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

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Studiekontakt

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Studieorter

  • Turkiet (Türkiye)
    • Eyalet/Yerleşke
      • Diyarbakır, Eyalet/Yerleşke, Turkiet (Türkiye), 21070
        • Rekrytering
        • Dicle University
        • Kontakt:
      • Diyarbakır, Eyalet/Yerleşke, Turkiet (Türkiye), 21070
        • Rekrytering
        • Gazi Yasargil Training and Research Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Group 1) Caudal Block Group
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.
Procedur: 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.
Aktiv komparator: Group 2) Non-Caudal Group
General anesthesia alone administered without caudal block for distal hypospadias repair. Intravenous analgesic agents used as per standard institutional protocol.
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of Urethrocutaneous Fistula
Tidsram: up to 3 months
Development of urethrocutaneous fistula following distal hypospadias repair, assessed by clinical examination
up to 3 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Pain Scores
Tidsram: Up to 24 hours postoperatively
Postoperative pain assessed using age-appropriate pain scales (e.g., Visual Analog Scale or FLACC scale, where higher scores indicate worse pain).
Up to 24 hours postoperatively
Surgical Complications
Tidsram: Up to 3 months
Incidence of surgery-related complications
Up to 3 months
Duration of Effective Analgesia
Tidsram: Up to 24 hours postoperatively
The time from the completion of the surgical/anesthetic procedure until the patient first requests or requires rescue analgesia.
Up to 24 hours postoperatively
Total Consumption of Rescue Analgesics
Tidsram: Up to 24 hours postoperatively
The total amount (mg) of rescue analgesic medications required by the patient during the postoperative period.
Up to 24 hours postoperatively

Samarbetspartners och utredare

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Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 december 2025

Primärt slutförande (Beräknad)

1 augusti 2026

Avslutad studie (Beräknad)

15 augusti 2026

Studieregistreringsdatum

Först inskickad

16 juni 2026

Först inskickad som uppfyllde QC-kriterierna

23 juni 2026

Första postat (Faktisk)

30 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 357/2025

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