Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair
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.
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Fikret Salık, associate professor
- 電話番号：+905076214125
- メール：fikretsalik@gmail.com
研究連絡先のバックアップ
- 名前：Fikret Salık
- 電話番号：05076214125
- メール：fikretsalik@gmail.com
研究場所
-
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Eyalet/Yerleşke
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Diyarbakır、Eyalet/Yerleşke、トルコ（Türkiye）、21070
- 募集
- Dicle University
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コンタクト：
- Fikret Salık
- 電話番号：05076214125
- メール：fikretsalik@gmail.com
-
Diyarbakır、Eyalet/Yerleşke、トルコ（Türkiye）、21070
- 募集
- Gazi Yasargil Training and Research Hospital
-
コンタクト：
- Mustafa Bıçak
- 電話番号：05320571437
- メール：drmustafabicak@gmail.com
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-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
|
General anesthesia alone administered without caudal block for distal hypospadias repair.
Intravenous analgesic agents used as per standard institutional protocol.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Urethrocutaneous Fistula
時間枠：up to 3 months
|
Development of urethrocutaneous fistula following distal hypospadias repair, assessed by clinical examination
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up to 3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Pain Scores
時間枠：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
|
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Surgical Complications
時間枠：Up to 3 months
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Incidence of surgery-related complications
|
Up to 3 months
|
|
Duration of Effective Analgesia
時間枠：Up to 24 hours postoperatively
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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
時間枠：Up to 24 hours postoperatively
|
The total amount (mg) of rescue analgesic medications required by the patient during the postoperative period.
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Up to 24 hours postoperatively
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 357/2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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