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临床试验/NCT02606578
NCT02606578终止不适用

Achalasia Patient Reported Outcomes

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Mayo Clinic
入组人数
200
试验地点
1
主要终点
Comparison of different surgical techniques with patient reported post-operative symptoms on the achalasia questionnaire

研究概览

简要总结

Patients that are either scheduled to undergo or have undergone an achalasia procedure at the Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather information and determine if one of these procedures is superior to the other.

详细描述

This is a non-randomized, non-inferiority trial that has been created to compare results of achalasia procedures including but not limited to: POEM + Partial Fundoplication (PF), POEM and Laparoscopic Modified Heller Myotomy + PF and POEM + Peroral Plication of the esophagus. Using a set of consistent evaluation tools for patients undergoing treatment for achalasia allows a standardized evaluation and comparison of these groups of patients. The long term and comparative POEM procedure outcomes are not currently known. Patients undergoing POEM, fundoplication, and/or laparoscopic myotomy report having varying degrees of symptoms of reflux, dysphagia, and pain. Providers also note varying degrees of esophagitis by endoscopy, reflux by impedance or pH scoring, and recurrence by repeat manometry. Many of these issues can be quantified using pH probe testing, upper GI endoscopy, high resolution manometry, CT scans, Endoflip device and esophagrams. There are various validated questionnaires that have been used to assess problem areas of reflux, dysphagia, and pain such as the Promis Global Health Score, Ekhardt Score, Mayo GER Score, Modified Dysphagia Questionnaire-30 Day, Zubrod Score, and pain scale. Each of these symptoms, tests, and questionnaires contributes to the provider's understanding of the patient's postoperative outcome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years old
  • Undergoing a POEM or laparoscopic modified heller myotomy and anti-reflux procedures
  • Esophagus diameter less <8 cm on barium swallow test

排除标准

  • Diverticular disease of the esophagus
  • Barrett's esophagus
  • Extensive abdominal adhesions
  • <50% predicted FEV1 on pulmonary function testing
  • Cardiac ejection fraction <25%
  • Esophageal stricture from prior myotomy
  • Sigmoidization of the esophagus
  • More than one prior balloon dilation (>3 cm) or any prior dilation of 3 cm

结局指标

主要结局

Comparison of different surgical techniques with patient reported post-operative symptoms on the achalasia questionnaire

时间窗: 2 years

Comparison of surgical techniques evaluated from the patient's medical record using patient reported post-operative symptoms on the achalasia questionnaire. The achalasia questionnaire includes quality of life, pain, activity level, heart burn, acid regurgitation, reflux, dysphagia, and diet.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Janani S. Reisenauer

Principal Investigator

Mayo Clinic

研究点 (1)

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