Treatment of Chronic Anal Fissure by Performing a Lateral Subcutaneous Sphincterotomy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Anal sphincter insufficiency
研究概览
简要总结
This study is aimed at studying the effectiveness and safety of surgical treatment of chronic anal fissure.
详细描述
A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and able-bodied adults, so the issue of treatment is of particular relevance.
The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy.The investigators plan to treat a chronic anal fissure by performing a lateral subcutaneous sphincterotomy, without excision of the fissure.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic anal fissure
排除标准
- •Inflammatory diseases of the colon
- •Pectenosis
- •Previous surgical interventions on the anal canal
- •IV grade internal and external hemorrhoids
- •Rectal fistula
- •Severe somatic diseases at the decompensation stage
- •Pregnancy and lactation
- •Anal sphincter insufficiency
结局指标
主要结局
Anal sphincter insufficiency
时间窗: Up to 60 days
Frequency of anal sphincter insufficiency according to the Wexner scale incontinence after the surgical intervention. Self reported daily meausure outcome, wich evaluate from 0 - to 20 points (where 0 points = full feacal continence; 20 points = full feacal incontinence).
次要结局
- 2-item pain intensity (P2)(On day 7, 30 and 60)
- Non-Healing Wound(On day 60)
- Profilometry /sphincterometry findings(On day 30 and 60)
- Temporary disability(Up to 60 days)
- Relap(Up to 60 days)