A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- The achalasia severity questionnaire score at 1 year.
研究概览
简要总结
The purpose of this study is to compare pneumatic dilatation and laparoscopic Heller myotomy in patients with achalasia in order to learn which of these two treatments should be recommended to patients in the future.
详细描述
Achalasia is a rare disease of the esophagus. It can cause difficulty swallowing, regurgitation of swallowed food, and chest pain. In achalasia, there are two problems in the esophagus. First, the esophagus does not properly push swallowed food down towards the stomach. Second, the valve at the lower end of the esophagus, called the lower esophageal sphincter, does not relax to allow food to pass from the esophagus into the stomach.
Achalasia cannot be "cured". However, the symptoms of achalasia can be improved by treatment. Treatment is usually directed towards reducing the degree of blockage caused by the lower esophageal sphincter. the muscle of the lower esophageal sphincter can be stretched using a technique called pneumatic dilatation, or it can be divided (cut in half) during a surgical operation. The operation is called laparoscopic Heller myotomy, and is done by laparoscopic ("keyhole") surgery, where small incisions are used and patients usually stay in hospital 1-2 nights. Other treatments for achalasia, such as medications or injection of Botulinum Toxin Type A are not often used because they do not provide effective long-term improvement.
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
- None
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
- •Clinical diagnosis of achalasia by a physician
- •manometric diagnosis of achalasia including both: Incomplete relaxation of the lower esophageal sphincter during swallowing (<80% of elevation over intragastric pressure and absence of esophageal peristalsis (peristalsis in <20% of initiated contractions)
- •Facility with English, ability to complete English language questionnaires
排除标准
- •Pseudoachalasia: esophageal carcinoma; esophageal stricture; previous esophageal or gastric surgery; previous instrumentation of the lower esophageal sphincter i.e. suture, polymer injection, silicone band
- •Previous gastric or esophageal surgery: fundoplication; Heller myotomy; gastric resection; vagotomy with or without gastric drainage
- •Age 17 year or less
- •Pregnancy
- •Presence of severe comorbid illness: unstable angina; recent myocardial infarction (<6 months), cancer (except integumentary), unless free of disease for more than 5 years; end stage renal disease; previous stroke with cognitive, motor speech, or swallowing deficit persisting longer than one month; severe respiratory disease; cognitive impairment
研究组 & 干预措施
1
pneumatic dilatation
干预措施: pneumatic dilatation (Procedure)
2
Laparoscopic myotomy
干预措施: laparoscopic myotomy with partial fundoplication (Procedure)
结局指标
主要结局
The achalasia severity questionnaire score at 1 year.
时间窗: Baseline, M2, M6, Yrs 1 to 5
次要结局
- Generic health related quality of life (SF-36)(baseline, M2, M6, Yrs 1 to 5)
- Gastrointestinal disease-specific quality of life (GIQLI)(baseline, M2, M6, Yrs 1 to 5)
- Measures of esophageal physiology(baseline, M6)
- Gastroesophageal reflux as measured by ambulatory 24-hr esophageal pH measurement(M6)
- Clinical outcomes of care including short term outcomes, major complications, and long-term clinical outcomes.(Yrs 1 to 5)