Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum (ZPOEM)

Methodist Health System

Status: Invitation-only

Conditions: Zenker Diverticulum

Treatments: Procedure: ZPOEM

Study type: Observational

Funder types: Other

Identifiers

NCT05157984

2020.11.16 (Other Identifier)

031.GID.2021.D

Details and patient eligibility

About

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.

Full description

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

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 2 patient groups

Retrospective cohort

Description:

Any patient of the physicians listed in this study who has undergone the ZPOEM procedure to treat ZD at Methodist Health System

Treatment:

Procedure: ZPOEM

Prospective cohort

Description:

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.

Treatment:

Procedure: ZPOEM