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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
|
有源比较器：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fistula Healing Rate at 6 Months
大体时间：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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.