Comparison of Post-operative Pain Between Fistula Laser Closure and Ligation of the Intersphincteric Tract in the Treatment of Anal Fistula - a Randomized Controlled Trial. (LASERLIFT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Post-operative pain score
研究概览
简要总结
This is a prospective, double-blinded randomised controlled trial conducted at two tertiary hospitals by a credentialed colorectal surgeon.
详细描述
Patients with high transphincteric fistulas were blinded and randomized to either laser or ligation of the fistula tract (LIFT). Pain scores at rest and movement, at 6 and 24 hours post operatively were measured using the visual analogue scale (VAS). Operative time was measured in minutes Continence and quality of life was assessed via the Wexner incontinence scale and SF-36 questionnaire respectively at 0, 3 and 6 months post-operatively.
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 (Outcomes Assessor)
盲法说明
Outcomes assessor was blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complex transphincteric fistulas:
- •high transphincteric fistula, involving more than 30% of the external anal sphincter
- •Multiple fistulas
- •Anterior fistulas
- •18-75 years old
- •Able to give consent
- •New or recurrent fistulas
- •Fistulas with or without setons
排除标准
- •Active perianal sepsis requiring drainage
- •Fistulas of non-cryptogladular origin- Crohn's, TB, malignancy
- •Expected lifespan less than 6 months
- •Pregnant women
- •Patients with more than 1 definitive surgery done for the fistula before
- •Patients with human immunodeficiency virus infection
- •Patients with pre-existing chronic pain disorders
- •Patients with Non-steroidal Anti-inflammatory Drug (NSAIDS) / Paracetamol allergies
结局指标
主要结局
Post-operative pain score
时间窗: 6 hours, 24 hours
Post-operative pain will be assessed by a blinded assessor using the Visual Analogue Scale (VAS), a validated pain score.
次要结局
- Continence(At baseline, and at 1 week, 1 month and 6 months post-operatively)
- Failure rate(6 months)
- Operative time(Intraoperative)
- Return to work(Number of days taken to return to work, assessed at 6 months post-operatively)
- SF36(At baseline, and at 1 week, 1 month and 6 months post-operatively)
- Duration of analgesia use(Number of days until cessation of analgesia use, assessed at 1 week or 1 month, whichever is shorter)