Impact of Gastric Length of Myotomy During Poem on Gastroesophageal Reflux : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Ph metry test for gastroesophageal reflux
研究概览
简要总结
This observational study will be conducted among 43 patients of both sexes in each group Study participants will be of the age more than 18 years
- STUDY PROCEDURE-Pre-defined technique to avoid bias and confounding due to multiple factors
- All the poem procedures will be performed by posterior route
- Preservation of sling fibers will be attempted in all the cases to avoid heterogeneity
- Length of esophageal myotomy will be kept constant (4-6cm)
- Double scope technique will be utilized to confirm the gastric extent of myotomy
First evaluation at 1-month: based on Symptoms
• Second evaluation: at 6 months by
- Objective evaluation: UGI endoscopy, High resolution manometry, Timed barium swallow
- Eckardt score, GERD-HRQL
- 24-hour pH study with manual readings
详细描述
• The primary outcome of the study is the incidence of significant reflux esophagitis (≥grade B) in cases with standard and extended gastric myotomies at 6 months after POEM
Secondary outcomes:
- Significant esophageal acid exposure (>6%) as defined by the revised Lyon consensus
- Symptoms of GERD (GERD HRQL)
- Clinical efficacy (Eckardt score≤3)
- Esophageal emptying at 5 minutes
- High resolution manometry parameters (LES pressures and Integrated relaxation pressure in mmhg units)
- All the secondary outcomes will be assessed at 6 months after poem procedure
Eligibility:
Eligible cases with idiopathic achalasia (type I and II) will be enrolled in the study and randomized (1:1 ratio) in two groups according to the length of gastric myotomies
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic achalasia (type I and II)
- •Age ≥18 years
- •Willing to provide informed consent and comply with the study protocol
排除标准
- •Ineligibility for POEM procedure
- •Spastic esophageal motility disorders
- •Presence of esophageal diverticulum and hiatal hernia
- •Prior hellers myotomy with or with out fundoplication
结局指标
主要结局
Ph metry test for gastroesophageal reflux
时间窗: 6 months
Significant esophageal acid exposure(\> 6%)
Impact of Gastric Length of myotomy during poem on Gastroesophageal reflux
时间窗: 6 months
incidence of reflux esophagitis \>grade B in cases with standard and extended gastric myotomies after POEM
次要结局
- Symptoms of Gastro esophageal reflux disease(6 months)
- High resolution manometry parameters(LES pressures and IRP)(6 months)
研究者
Mohan Ramchandani
PRINCIPAL INVESTIGATOR
Asian Institute of Gastroenterology, India