LATFIA-trial: Laser Assisted Treatment of Fistula In Ano Randomized Controlled Trial Comparing FiLaCTM to Rectal Advancement Flap
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 10
- 主要终点
- Primary fistula closure after index laser or flap treatment
研究概览
简要总结
Randomised Controlled Trial comparing Laser assisted closure of transsphincteric fistula to the rectal advancement flap.
详细描述
A prevalent and complex fistula type is the high transsphincteric (TS) fistula. It typically runs through the upper two-thirds of the external anal sphincter (EAS) and is, due to the high risk of fecal incontinence, not suitable for fistulotomy and sphincter sparing treatment is required. To be included in this trial the participants should have a single, continuous TS fistula of cryptoglandular origin, that is treated by loose seton drainage for at least 2 months and is mapped by MRI. Participants with IBD, hidradenitis suppurativa or a malignant fistula will be excluded. Intervention Fistula Laser Closing (FiLaCTM) (Biolitec, Germany) is an endofistular technique, using a radial-emitting laser fiber that emits laser light with a maximum penetration depth of 2 - 3 mm. It destroys both the crypt gland and the additional epithelial layer of the fistula without damaging the sphincter. The fiber is inserted until the internal opening, activated and pulled backwards slowly, allowing the laser to have its effect. The external opening is excised and the internal opening is closed with a single absorbable suture. Rectal advancement flap is currently the gold standard for sphincter sparing treatment of high transsphincteric fistulae. The fistula is cored out and an advancement flap is made of mucosa and submucosa. The opening of the fistula in the flap is excised, the residual internal opening is closed with absorbable suture and the flap is sutured below the fistula to the anoderm. The advancement flap is a difficult technique that requires a relatively large transanal dissection that results in postoperative pain and may lead to disturbances in continence. Preliminary results with the Filac technique show fistula healing rates comparable to the advancement flap. Due to its simplicity, speed and minimal invasiveness the investigators expect a benefit for the participants in terms of postoperative pain, operating time and quality of life.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with fistula involving more than one-third of the external anal sphincter
- •Single, continuous fistula tract at time of inclusion
- •Loose seton present in fistula tract for 2 months or more at time of inclusion
- •Able to complete an informed written consent, understand its implications and contents, and participate in follow-up
排除标准
- •Fistula tract < 1 cm
- •Complex fistula tract system (branching of fistula tract inside the sphincter complex)
- •Pregnancy
- •HIV-positive
- •Crohn´s disease, Ulcerative colitis
- •Fistula due to malignancy
- •Tuberculosis
- •Hidradenitis Suppurativa
- •No internal opening
- •Unable to undergo or contraindications to MRI
结局指标
主要结局
Primary fistula closure after index laser or flap treatment
时间窗: 6 months
Success rate (number of patients) of laser/flap treatment defined as full healing (fistula closure) after the index procedure
次要结局
- Postoperative Pain(6 months)
- Postoperative fecal incontinence(6 months)
- Postoperative wound complications(6 months)
- Secondary Fistula closure(6 months)
- Postoperative Quality of Life(6 months)
- Identify predictive factors for clinical fistula healing to determine the treatment indications.(6 months)
- Primary Recurrence(6 months)
- Secondary Recurrence(12 months)