CTRI/2025/03/082324尚未招募3 期
A comparative study of topical 2 percent of Diltiazem gel versus lateral internal sphincterotomy in the treatment chronic fissure in Ano in a tertiary care centre in Nagpur a randomized control trial
Dr. Tippanna Talwar1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月23日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain relief will be assessed using Visual Analogue Scale on post intervention 1, 4 and 6 week
研究概览
简要总结
All clinically diagnosed cases of chronic fissure in ano will be divided into two groups. Group 1 patients will be treated with 2% Diltiazem gel. Group 2 patients will be treated with lateral internal sphincterotomy. Both groups will be followed up on 1st, 4th and 6th week on OPD basis to assess the outcomes as listed above. The rationale is to explore the role of topical 2% diltiazem as effective and safe alternative to lateral internal sphicterotomy for treatment of chronic fissure in ano.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed as case of Chronic Fissure in Ano Patients between 18 to 60 years of age of either gender.
排除标准
- •Childrens and mentally handicapped patients.
- •Recurrent fissures.
- •Fissures along with hemorrhoids or /and fistula Fissures associated with malignancies ,other comorbidities condition like diabetes mellitus, hypertension etc .
- •Fissures secondary to specific diseases like tuberculosis, Crohn’s disease ,PLHIV, etc.
结局指标
主要结局
Pain relief will be assessed using Visual Analogue Scale on post intervention 1, 4 and 6 week
时间窗: 1, 4 and 6 week
次要结局
- Change in Anal tone pressure will be assessed by Sphinctometer on 1,4,and 6 weeks(1, 4 and 6 weeks)
研究者
Dr Divish Saxena
All India Institute of Medical Sciences Nagpur
研究点 (1)
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