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| ID | Type | Description | Link |
|---|---|---|---|
| 2020.11.16 | Other Identifier | Baylor Scott and White |
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| Name | Class |
|---|---|
| Baylor Scott and White Health | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective cohort | Any patient of the physicians listed in this study who has undergone the ZPOEM procedure to treat ZD at Methodist Health System |
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| Prospective cohort | Any patient of the physicians listed in this study who has undergone the ZPOEM procedure to treat ZD at Methodist Health System and has agreed to be follow-up post-procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZPOEM | Procedure | Zenker's diverticulum management by Per oral endoscopic myotomy (POEM) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | January 2017 to December 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Follow up of patients who had the 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with Zenker's diverticulum (ZD) and who have undergone the ZPOEM procedure, as well as patients who will have this procedure in the future
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| Name | Affiliation | Role |
|---|---|---|
| Prashant Kedia, MD | Methodist Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
Participant data will be shared only with Baylor, Scott & White. All data will be de-identified and in compliance with the Data User Agreement in place between both institutions.
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| ID | Term |
|---|---|
| D016672 | Zenker Diverticulum |
| ID | Term |
|---|---|
| D004936 | Diverticulum, Esophageal |
| D004240 | Diverticulum |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
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| June 2021 to December 2025 |
| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |