Open Fistulectomy vs. Laser Closure for Low Perianal Fistula
Open Fistulectomy Versus Fistula Tract Laser Closure in Low Perianal Fistula
Perianal fistula is an abnormal tunnel connecting the anal canal to the perianal skin, frequently causing chronic pain, discharge, and impaired quality of life. Traditional open fistulectomy is an established treatment with high healing rates, but it leaves an open wound that requires prolonged recovery and carries a risk of anal sphincter injury. Fistula-tract Laser Closure (FiLaC) is a minimally invasive, sphincter-preserving technique that uses laser thermal energy to close the tract from within while minimizing tissue trauma.
This study is a prospective, randomized controlled trial designed to compare the efficacy and safety of open fistulectomy versus laser fistulotomy in adult patients with primary low perianal fistula.
Participants are randomly assigned to one of two surgical treatment groups:
- Group 1: Laser fistulotomy (FiLaC) using a 1470 nm diode laser probe to seal the tract, combined with internal opening closure.
- Group 2: Conventional open fistulectomy involving complete excision of the fistula tract, allowing the wound to heal by secondary intention.
Patients are evaluated during surgery and followed postoperatively at 24 hours, 48 hours, 1 week, 2 weeks, 4 weeks, 3 months, and 6 months. The primary goals are to assess fistula healing rates and postoperative pain levels. Secondary goals include evaluating operative time, intraoperative blood loss, wound healing duration, complication rates, time to return to daily activities, fecal continence (measured by the Wexner Continence Score), and quality of life.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adult patients aged 18 years and above.
- Diagnosis of primary (non-recurrent) low perianal fistula (intersphincteric or low transsphincteric involving less than one-third of the external sphincter) confirmed by clinical examination.
- Fistula tract anatomy confirmed by preoperative endoanal ultrasound (EAUS) and/or pelvic MRI.
- Fit for surgery under spinal or general anesthesia.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Complex or high perianal fistulae (suprasphincteric, extrasphincteric, or involving more than one-third of the external sphincter).
- Recurrent or previously operated perianal fistulae.
- Crohn's disease or other inflammatory bowel disease-associated fistulae.
- Active anorectal sepsis or undrained abscess at the time of enrollment.
- Immunocompromised patients (e.g., HIV/AIDS, long-term systemic corticosteroid therapy, post-organ transplantation).
- Pre-existing fecal incontinence (baseline Wexner Continence Score > 5).
- Pregnant or breastfeeding females.
- Known bleeding disorders or therapeutic anticoagulation that cannot be temporarily safely discontinued.
- History of prior pelvic irradiation.
- Inability or unwillingness to comply with the postoperative follow-up protocol.
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Laser Fistulotomy (FiLaC)
Patients undergo Fistula-tract Laser Closure (FiLaC™) using a 1470 nm diode laser system.
The internal opening is curetted and sutured closed with polyglycolic acid suture.
Granulation tissue is debrided with a fistula brush, and a radially emitting laser probe is introduced through the external opening to deliver energy circumferentially (10-14 W) at a continuous withdrawal rate of 1 mm/s to obliterate the tract.
The external opening is left open or loosely sutured for drainage.
|
Debridement of the fistula tract using a fistula brush followed by closure of the internal opening with 2/0 polyglycolic acid suture.
Photothermal obliteration of the tract is achieved using a 1470 nm diode laser system with a 360-degree radial emitting fiber delivering energy circumferentially (10-14 W) during steady withdrawal at 1 mm/s.
|
|
アクティブコンパレータ：Open Fistulectomy
Patients undergo conventional open fistulectomy.
The fistula tract is cannulated with a malleable probe, followed by complete surgical excision of the tract and its epithelialized lining using electrocautery and sharp dissection.
The surgical wound is left open to heal by secondary intention, with wound edge marsupialization performed as needed to prevent premature skin bridging.
|
Complete surgical excision of the fistulous tract from the external opening to the internal opening using sharp dissection and electrocautery over a probe guide.
The resulting wound is left open to heal by secondary intention with wound edge marsupialization performed as necessary.
|
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 |
|---|---|---|
|
Fistula Healing Rate at 6 Months
時間枠：6 months postoperatively
|
Percentage of participants achieving complete clinical fistula healing, defined as complete epithelialization of the surgical site and external wound with total absence of discharge or purulent drainage on clinical examination, without the need for secondary surgical intervention.
|
6 months postoperatively
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- FiLaC vs Open Fistulectomy
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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