Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair: a Multicenter, Randomized, Open-label, Parallel Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- Healing time
研究概览
简要总结
The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.
详细描述
The management of trans-sphincteric anal fistulae of cryptoglandular origin is challenging. The ideal management is to effectively heal the fistula without compromising continence, avoid fistula recurrence, and quick recovery. Ligation of the intersphincteric fistula tract (LIFT) and LIFT reinforced with a bioprosthetic graft (BioLIFT) are two recently reported procedures that showed improved healing results. In the LIFT, Rojanasakul et al proposed to identify the fistula tract in the intersphincteric space and subsequent division and ligation of the tract, and the primary healing rate was 94.4%. The following studies reported slightly lower results, but the recurrence rate was as high as 18% to 28%. Ellis et al subsequently described a modified LIFT procedure (BioLIFT procedure) in which a bioprosthetic was placed in the intersphincteric plane to reinforce the closure of the fistula tract (BioLIFT procedure), and yielded a healing rate of 94% in 31 patients who had a minimum of 1 year of follow-up after their last treatment.
The investigators modified the LIFT procedure by combining LIFT with the technique of anal fistula plug. The bioprosthetic plug was placed into the fistula tract through the opening in the external sphincter to the external opening in the skin after LIFT procedure. The present study was designed to assess the preliminary results of LIFT-Plug technique prospectively.
The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair.
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
- •Male or female subjects over eighteen years old or less than 65 years old.
- •Able to understand and provide informed consent or have a legally authorized representative capable of providing consent.
- •Clinical diagnosis of primary anal fistula categorized as trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent).
排除标准
- •Presence of horseshoe fistula.
- •History of immunosuppression therapy/treatment within previous six months.
- •Fistulas with active abscess, infection, or acute inflammation
- •History of Choron's Disease
- •History of Ulcerative Colitis
- •History of HIV or other immune system disease
- •History of collagen disease
- •History of radiation to the anorectal region
- •Allergies to pig tissue or pig products
- •Religious or cultural objection to the use of pig tissue
研究组 & 干预措施
LIFT
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure
干预措施: LIFT (Procedure)
LIFT-plug
Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure
干预措施: LIFT-plug (Procedure)
结局指标
主要结局
Healing time
时间窗: 1month, 3 month, 6 month postoperatively
次要结局
- postoperative pain(1month, 3 month, 6 month postoperatively)
- fecal incontinence(1month, 3 month, 6 month postoperatively)
- recurrence rate(1month, 3 month, 6 month postoperatively)
- complication rates(1month, 3 month, 6 month postoperatively)
研究者
Zhen Jun Wang
Clinical Professor
Beijing Chao Yang Hospital