Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Duration of healing
研究概览
简要总结
The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence.
详细描述
The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence. We hypothesized that performing internal sphincterotomy in a point midway between the standard lateral position and the posterior midline position would confer better healing and relief of symptoms with less incidence of fecal incontinence while avoiding the development of keyhole deformity.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of both genders with chronic posterior anal fissure were included to the study.
排除标准
- •Patients with anterior or lateral anal fissure,
- •patients with previous anal surgery,
- •patients with concomitant anorectal pathology,
- •patients with secondary anal fissure due to Crohn's disease or other specific etiology,
- •patients with any degree of fecal incontinence,
- •patients with active anorectal sepsis.
研究组 & 干预措施
Posterolateral sphincterotomy
Division of internal anal sphincter at 5 o'clock position
干预措施: posterolateral sphincterotomy (Procedure)
Lateral sphincterotomy
Division of internal anal sphincter at 3 o'clock position
干预措施: lateral sphincterotomy (Procedure)
结局指标
主要结局
Duration of healing
时间窗: 6-8 weeks after surgery
The time to complete healing of anal wound defined by complete epithelization of the wound
次要结局
- Anal pain(1-6 weeks after surgery)
研究者
Sameh Emile
Lecturer of general surgery
Mansoura University