A prospective comparative evaluation of short length myotomy versus standard normal myotomy in patients undergoing per oral endoscopic myotomy for achalasia cardia type 1
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The primary outcome is symptom resolution with Eckardt score normalizing to 3/12 with basal LES pressures below 20 mm of mercury and IRP values 15 mm of mercury.
研究概览
简要总结
Per-oral endoscopic myotomy (POEM) was developed from this technique andfeatures the creation of a submucosal tunnel enabling the LES myotomy to beperformed away from the mucosal entry site which is closed at the end of theprocedure.
This is an internationally well recognised and established procedure to treat patients with achalasia cardia. we only seek to modify the procedure which will reduce operative time and complications.
As the patients in type 1 achalasia have no peristalsis and no motilityin the oesophagus a longer length myotomy often does not add any extratherapeutic benefit to the patient.
As such there is no difference in the procedure hence the adverse eventsare comparable in both groups of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with type 1 achalasia cardia.
排除标准
- •1>Patients who are below 18 years age 2>Patients who are pregnant or breast feeding 3>Patients who are unable to give consent 4>Patients with indeterminate type of achalasia or patients not fit for general anaesthesia.
- •5>Patients with advanced sigmoid type 2 oesophagus.
结局指标
主要结局
The primary outcome is symptom resolution with Eckardt score normalizing to 3/12 with basal LES pressures below 20 mm of mercury and IRP values 15 mm of mercury.
时间窗: This will be assessed at week 4, 12 and 1 year
次要结局
- 1Technical success- This is defined as an adequate length myotomy on the oesophageal and gastric side has been achieved(2Treatment success- Relief from the symptoms of achalasia with the Eckardt score normalizing, IRP and basal LES pressures normalizing on HRM)