Lateral Internal Sphincterotomy versus Manual Anal Dilatation in Chronic Anal Fissure- A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- To determine post operative pain and incontinence in subjects with Chronic Anal Fissure undergoing Lateral Internal Sphincterotomy compared with Manual Anal Dilatation.
研究概览
简要总结
Two surgical methods are compared here. Manual anal dilatation is one of the ancient and simple surgery, but with high incidence of recurrence and incontinence. Lateral internal sphincterotomy is the most preferred procedure in the current days but again with incidence of incontinence.(3)
Atleast 5 month follow up of 99 patients treated by sphincter stretch and reported recurrence rate of16%. Sphincterotomy results in sustained reduction of maximum resting anal pressure.(4)
Hiltunen et al, found that the basal pressure was comparatively lower in the patients who underwent LIS, after 2 months of surgery,however, there were 4 failures among the 19 patients who underwent MAD. Many studies have demonstrated lower incontinence rate following LIS compared to MAD.
Hareesh GSR et al described that in a sample of 60 patients, 4 (6.67%) patients were experiencing nocturnal soiling and 56 (93.33%) patients are not having nocturnal soiling. In MAD, 3 (10.0%) patients were experiencing Nocturnal soiling whereas in LAS, only 1 (3.3%) patient had Nocturnal soiling as complication.
Rakesh Kumar et al described that, over the period of 9 month follow-up, 8 (16%) and 1 (2.27%) patients in LIS group and MAD group respectively reported with recurrence of symptoms and the fissure was evident on examination also (p = 0.05).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Chronic Anal Fissure( ≥ 6 weeks of duration) 2) Age 20-60years.
- •Failed conservative management.
- •(Not responded to conservative management of chronic anal fissure for ≥ 6weeks).
排除标准
- •Patients with Chronic Anal Fissure( ≥ 6 weeks of duration) 2) Age 20-60years.
- •Failed conservative management.
- •(Not responded to conservative management of chronic anal fissure for ≥ 6weeks).
结局指标
主要结局
To determine post operative pain and incontinence in subjects with Chronic Anal Fissure undergoing Lateral Internal Sphincterotomy compared with Manual Anal Dilatation.
时间窗: 24 hours after surgery, at the time of discharge, 1st month, 2nd month and 3rd month
次要结局
- To determine the rate of ulcer healing in Lateral Internal Sphincterotomy compared with Manual Anal Dilatation in subjects with Chronic Anal Fissure.(24 hours after surgery, at the time of discharge, 1st month, 2nd month and 3rd month)