Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Retrospective chart review / Compartive analyses; t-tests and Wilcoxon-Mann-Whiteney Test; Chi-square or Fisher's exact test; and Pearson correlation coeffecient or Spearman's rank-order correlation
研究概览
简要总结
This is a multicenter investigator-initiated trial between Baylor-Scotts & White (BSW) and Methodist Health System (MHS). This study will be conducted via a retrospective review and a prospective patient registry. Patients who have undergone the ZPOEM procedure performed by the physicians listed in this protocol will be included, as well as patients who will have this procedure in the future. Data that will be collected at MHS will be entered into an Excel spreadsheet. Patient demographic information will be collected via a review of subjects' electronic medical records. Available patient outcomes will be collected via a review of electronic medical records. This review will be conducted from 1/1/2017 through 12/31/2025.
详细描述
This is a multicenter investigator-initiated trial between Baylor-Scotts & White (BSW) and Methodist Health System (MHS). This study will be conducted via a retrospective review and a prospective patient registry. Patients who have undergone the ZPOEM procedure performed by the physicians listed in this protocol will be included, as well as patients who will have this procedure in the future. Data that will be collected at MHS will be entered into an Excel spreadsheet. Patient demographic information will be collected via a review of subjects' electronic medical records. Available patient outcomes will be collected via a review of electronic medical records. This review will be conducted from 1/1/2017 through 12/31/2025.
To obtain the follow-up information, potential subjects will be identified using the same process described in the previous paragraph and will be contacted by a member of the institution's research team to answer questions about their symptoms post-surgery. These are listed in the ZPOEM Data Collection Sheet. These questions may be administered over the phone, via email, or by mail. Subjects enrolled in the patient registry will have follow-up data collected at 2-time points: 2 weeks post-op and 3 months post-op.
Primary endpoints and other variables to be collected are those listed on the ZPOEM Data Collection Sheet. Primary subject endpoints include, but are not limited to:
- Dysphagia score(s) - depending on what is available in EMR
- Weight gain following surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Patients 18 years of age or older
- •Any patient of the physicians listed in this study who has undergone the ZPOEM procedure to treat ZD at MHS
- •For prospective registry: Ability to give informed consent
排除标准
- •For prospective registry: Unable or not willing to provide informed consent
结局指标
主要结局
Retrospective chart review / Compartive analyses; t-tests and Wilcoxon-Mann-Whiteney Test; Chi-square or Fisher's exact test; and Pearson correlation coeffecient or Spearman's rank-order correlation
时间窗: January 2017 to December 2025
Retrospective review of patient records who have had ZPOEM procedure, compartive analyses will be performed by employing statistical tests such as t-tests and Wilcoxon-Mann-Whiteney Test; Chi-square or Fisher's exact test; and Pearson correlation coeffecient or Spearman's rank-order correlation depdening on the data distribution. Multivariate analyses will be employed with a p-value \<0.05 will indicate statistical significance.
次要结局
- Prospective follow-up of patients/ Compartive analyses; t-tests and Wilcoxon-Mann-Whiteney Test; Chi-square or Fisher's exact test; and Pearson correlation coeffecient or Spearman's rank-order correlation(June 2021 to December 2025)