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ACTIVE NOT RECRUITING
NCT04450628
NA

Esophagogastric Junction Distensibility During Hiatal Hernia Repair

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. The investigators also aim to assess for any correlation between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia scores.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2020-09-28

Completion Date

2026-09

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DEVICE

EndoFLIP

Intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the esophagogastric junction using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.

Locations (1)

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, United States