NCT06870630招募中不适用
Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients
Asian Institute of Gastroenterology, India2 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2023年11月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Incidence of true reflux based on 24-hour pH impedence
研究概览
简要总结
- Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. A clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. Written informed consent will be obtained from all participants. In this study, the participants and the care-provider assessing the clinical response to the POEM procedure at 3months will be blinded to the allocation.
详细描述
. Primary objective -
• To study the incidence of true reflux on 24 hour pH analysis with manual study.
Secondary objective -
- To analyse treatment success which is defined as Eckdart score < 3 at follow up assessment ( 3rd month)
- To analyse the recovery of peristalsis after POEM using High resolution manometry
- To study total procedure time , intra operative adverse effects and duration of hospital stay.
- Severity of oesophagitis
- Presence of GERD symptoms based on GERD questionnaire & Quality of life questionaire post procedure.
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
- Single (Participant)
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
- •Adult >18 years
- •Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.
排除标准
- •Patients with Type 1 & 3 ACHALASIA CARDIA
- •Patients with previous endoscopic or surgical treatment for achalasia
- •Patients with standard exclusion criteria for POEM procedure such as contraindication to general anesthesia, coagulopathy (international normalized ratio > 1.5, platelet count < 50 000/μL), portal hypertension, pregnancy, breast feeding women, and diffuse scarring in the esophagus due to previous surgery or radiation.
结局指标
主要结局
Incidence of true reflux based on 24-hour pH impedence
时间窗: 3 months
Reflux parameters in percent are noted in impedence report like acidic and non acidic refluxes
Integrated Relaxation Pressure (IRP) at High resolution manometry test
时间窗: 3 months
IRP in mm Hg measures pressure in the esophagus
次要结局
未报告次要终点
研究者
Mohan Ramchandani
Director
Asian Institute of Gastroenterology, India
研究点 (2)
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