Health-Related Quality of Life After Peroral Endoscopic Myotomy for Patients With Achalasia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Achalasia symptom questionnaire (ASQ)
研究概览
简要总结
Achalasia is an esophageal motility disorder, characterized by insufficient lower esophageal sphincter relaxation and loss of esophageal peristalsis. Patients with achalasia experience distressing gastrointestinal symptoms, including dysphagia, reflux and chest pain, which lead to weight loss and malnutrition. Undoubtedly, health-related quality of life can be significantly diminished in patients with achalasia. At present, POEM has become one of the standard therapies for achalasia. Limited studies have focused on the patient's quality of life before and after POEM. The present study aimed to assess the changes in quality of life of patients with achalasia using the validated achalasia severity questionnaire (ASQ) and the short form (SF)-36 scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as achalasia base on high resolution manometry, barium esophagram and upper endoscopy
- •Scheduled to undergo POEM for treatment of achalasia
排除标准
- •Coagulopathy and systemic disorders that precluded safe general anesthesia
结局指标
主要结局
Achalasia symptom questionnaire (ASQ)
时间窗: Baseline, Change from Baseline ASQ score at 3 months and 12 months after treatment
Achalasia symptom questionnaire assess the disease-specific health-related quality of life by sampling the concepts of food tolerance, dysphagia-related behavior modifications, pain, heartburn, distress, lifestyle limitation, and satisfaction in 10 items. The total range is 10 to 31, with higher scores indicating worse quality of life (Urbach et al, Am J Gastroenterol 2005).
Short form (SF)-36
时间窗: Baseline, Change from Baseline SF-36 score at 3 months and 12 months after treatment
The short form (SF)-36 (best score 100, worst score 0). The short form (SF)-36 assess the health-related quality of life from 8 aspects, including physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health in 36 items. The total range is 0 to 100, with lower scores indicating worse quality of life (Ware et al, J Clin Epidemiol 1998).
次要结局
- Reflux esophagitis on post-POEM endoscopy(3 months after treatment)
- Eckardt score(baseline, 3 months and 12 months after treatment)
- Gastroesophageal reflux disease questionnaire (GerdQ) score(baseline, 3 months and 12 months after treatment)
研究者
Xiangbin Xing
Principal Investigator
First Affiliated Hospital, Sun Yat-Sen University