Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- macroscopic healing of the fissure
研究概览
简要总结
The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared to a relatively new treatment (injection of Botox in the internal anal sphincter). The study hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison is done blinded for the surgeon and the patient.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic
排除标准
- •pregnancy
- •previous anal surgery
- •Crohn's disease
- •systemic causes of an anal fissure
研究组 & 干预措施
Botox injection
injection of 10U of BT (Botox®; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline. In addition, a placebo ointment has to be applied to the anoderm six times a day
干预措施: Botox (Procedure)
ISDN ointment
application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter
干预措施: Botox (Procedure)
ISDN ointment
application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter
干预措施: ISDN ointment (Drug)
ISDN ointment
application of ISDN 1% ointment 6 times a day. injection of placebo into internal anal sphincter
干预措施: Placebo (Drug)
结局指标
主要结局
macroscopic healing of the fissure
时间窗: 4 months
次要结局
- complications(12 months)
- fissure recurrence(12 months)
- fissure related pain(12 months)
- costs(12 months)