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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
활성 비교기: 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.
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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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fistula Healing Rate at 6 Months
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- FiLaC vs Open Fistulectomy
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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