跳至主要内容
临床试验/NCT02530983
NCT02530983招募中不适用

Mayo Clinic Upper Digestive Disease Survey

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
1,000
试验地点
1
主要终点
Completion of the Mayo Clinic Upper Digestive Disease Survey by patients at varying time points following surgery

研究概览

简要总结

The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a consistent evaluation tools for patients undergoing esophageal reconstruction or treatment or patients that are experiencing an upper digestive disease in order to standardize and validate outcome measures. Data will be used to establish the validation of the questionnaires/survey. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure and for upper digestive diseases. Data will contribute to creating treatment algorithms for symptom management for upper digestive diseases and for post-operative complications and symptoms as well as contribute to pre-operative education.

详细描述

The Mayo Clinic Conduit Report Card Questionnaires are a compilation of standard questionnaires and questions that have been created specifically for this study some of which are patient report and others that are administered by the provider or study staff. It includes the Promis Global Health Score, modified Mayo GER Score questions, modified Dysphagia Questionnaire-30 Day questions, and Zubrod Score. It also includes a 10-point scale to grade postoperative pain, milk assessment, Modified Mayo Reflux Score adapted from the Mayo Clinic Reflux Score, Dumping Score adapted from Sigstad's Scoring System, Simple Dysphagia Score adapted from Mellows and Pinkas, Stricture Score adapted from Blackmon, et al., Pyloric Spasm Score, and Conduit Emptying Score abstracted from Vaezi, Baker, Achkar, and Richter. We will also be collecting information on their demographics, operation, nutritional status, laboratory values, testing results and clinical outcomes.

Patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients who undergo surgery and at one month following diagnosis and then every three months for 1 year after diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients that do not undergo surgery. The questionnaire can be completed at their clinic visit, over the telephone, or by mail using the paper form or may be completed using an electronic application. The electronic version is available for Mayo Clinic and non Mayo Clinic patients through the app store in conjunction Mayo IT.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.

排除标准

  • 未提供

结局指标

主要结局

Completion of the Mayo Clinic Upper Digestive Disease Survey by patients at varying time points following surgery

时间窗: 1 year

Completed Mayo Clinic Upper Digestive Disease Survey will be analyzed and used to establish validation.

次要结局

  • Establishment of "normal" or expected scores from the Mayo Clinic Upper Digestive Disease Survey(3 years)

研究者

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

Luis F. Tapias Vargas

Principal Investigator

Mayo Clinic

研究点 (1)

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