Randomized Controlled Trial Comparing Fistulotomy vs LIFT Plus Laser Ablation vs Open LIFT Plus Laser in the Treatment of Trans-sphincteric Perianal Fistula
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- healing
研究概览
简要总结
>This randomized clinical trial compares three different surgical techniques for the treatment of transsphincteric perianal fistula: (1) traditional fistulotomy (lay open), (2) ligation of the intersphincteric tract (LIFT) with adjunctive endofistula laser ablation, and (3) open LIFT procedure followed by direct laser ablation of the tract under vision. The aim is to determine which approach offers the highest healing rate, lowest recurrence, and best postoperative outcomes with minimal impact on continence.
详细描述
> Transsphincteric perianal fistula presents a surgical challenge due to the need to balance fistula eradication with continence preservation. While fistulotomy is associated with high healing rates, it carries a risk of sphincter damage. Ligation of the intersphincteric tract (LIFT) offers a sphincter-sparing alternative, and the use of endofistula laser ablation (FiLaC or diode laser) has shown promise in enhancing outcomes.
This study will enroll 90 patients with confirmed transsphincteric cryptoglandular perianal fistula and randomize them equally into three arms:
Group A: Conventional fistulotomy (lay open).
Group B: LIFT procedure with endofistula laser ablation using a radial laser fiber.
Group C: Open LIFT with direct laser ablation of the tract under vision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65
- •Confirmed diagnosis of transsphincteric cryptoglandular perianal fistula
- •Primary (first-time) surgery
- •Able to provide informed consent
排除标准
- •Crohn's disease or other inflammatory bowel disease
- •Suprasphincteric, extrasphincteric, or horseshoe fistulas
- •Previous fistula surgery
- •Active perianal abscess
- •Current immunosuppression
- •Pregnant or breastfeeding women
结局指标
主要结局
healing
时间窗: 6 months
Baseline Fistula manegment score → Pre-op disease severity Post-op Fm-score at 1, 3, 6 months → Objective clinical healing Where Total score = Pain + Discharge + Continence + QOL with Range = 0-16 Pain (0-4) 0 No pain 1. Mild, occasional pain, no analgesics needed 2. Moderate pain occasional analgesics 3. Severe pain regular analgesics 4. Constant, severe pain interfering with daily activities Discharge (0-4) 0 No discharge 1 Occasional spotting, no pad required 2 Daily discharge, small amount, 1 pad/day 3 Moderate discharge requiring \>1 pad/day 4 Persistent heavy discharge; soaking pads; malodorous Continence (0-4) 0 Full continence 1 Gas incontinence only 2 Occasional soiling or minor liquid incontinence 3 Frequent soiling; liquid stool incontinence 4 Solid stool incontinence Quality of Life (QoL) 0 No impact on life 1. Mild limitation 2. Moderate impact 3. Significant impact 4. Severe impairment Interpretation of healing 0-3 Minimal 4-7 Mild disease 8 - 11 moderate 12 - 17 severe
次要结局
- Fistula manegment score above 7 consider non healing(12 months)
- continence level. Assessed by wexener incontinence score(6 months)