Esophagogastric Junction Distensibility During Hiatal Hernia Repair
Esophagogastric Junction Distensibility, Hiatal Hernia
About this trial
This is an interventional treatment trial for Esophagogastric Junction Distensibility focused on measuring EndoFLIP, Distensibility of the esophagogastric junction, Gastroesophageal Reflux Disease-Health Related Quality of Life survey, Mayo Dysphagia Questionnaire
Eligibility Criteria
Inclusion Criteria:
- Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication
- Absence of spastic esophageal disorders (i.e. jackhammer esophagus, achalasia types I-III) or esophageal dysmotility (any evidence of ineffective esophageal motility disorder with failed swallows in > 50% of swallows and DCI < 450, or fragmented peristalsis as defined by Chicago Classification) assessed by preoperative high-resolution manometry
- Adult patients ≥18 years
- Elective repairs
Exclusion Criteria:
- Redo hiatal hernia repairs
- Emergent repairs
- Patients with contraindication to surgery or endoscopy
- Patients with esophageal varices
- Cases with insufficient esophageal length in which fundoplication is unable to be performed or a Collis gastroplasty is required
- Presence of IEM on Manometry
- Connective tissue diseases such as scleroderma or lupus
Sites / Locations
- Atrium Health - Carolinas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Surgeon blinded
Surgeon unblinded
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.
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.