Esophagogastric Junction Distensibility During Hiatal Hernia Repair

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication

• Absence of spastic esophageal disorders (i.e. jackhammer esophagus, achalasia types I-III) assessed by preoperative high-resolution manometry

• Adult patients ≥18 years

• Elective repairs

Locations
United States
North Carolina
Atrium Health - Carolinas Medical Center
RECRUITING
Charlotte
Contact Information
Primary
Greg T Scarola, MS, MBA
Gregory.Scarola@atriumhealth.org
704-355-5379
Time Frame
Start Date: 2020-09-28
Estimated Completion Date: 2026-08
Participants
Target number of participants: 50
Treatments
No_intervention: Surgeon blinded
During blinded cases no adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values.~Surgery will be scheduled and patients will undergo 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 EGJ 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.
Experimental: Surgeon unblinded
The surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication. The data will be evaluated to assess if intraoperative calibration influences postoperative symptoms by comparing the two groups.~Surgery will be scheduled and patients will undergo 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 EGJ 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.
Sponsors
Collaborators: Medtronic
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov