Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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

Official Title
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Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum

Conditions
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Zenker Diverticulum

Intervention / Treatment
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* Procedure: ZPOEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: For prospective registry: Unable or not willing to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective cohort<br>Any patient of the physicians listed in this study who has undergone the ZPOEM procedure to treat ZD at Methodist Health System | Procedure: ZPOEM<br>* Zenker's diverticulum management by Per oral endoscopic myotomy (POEM)<br>* Other names: peroral endoscopic myotomy (POEM);|
| Prospective cohort<br>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. | Procedure: ZPOEM<br>* Zenker's diverticulum management by Per oral endoscopic myotomy (POEM)<br>* Other names: peroral endoscopic myotomy (POEM);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | June 2021 to December 2025 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zenker's Diverticulum, peroral endoscopic myotomy