Status:
RECRUITING
Esophagogastric Junction Distensibility During Hiatal Hernia Repair
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Medtronic
Conditions:
Esophagogastric Junction Distensibility
Hiatal Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 planimetr...
Detailed Description
Patients referred for antireflux surgery and/or hiatal hernia repair will be considered for enrollment. Standard preoperative evaluation will include esophagogastroduodenoscopy (EGD) to assess for int...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Connective tissue diseases such as scleroderma or lupus
- Diameter measurements less than 5 mm as the EF-325N catheter is not suitable
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04450628
Start Date
September 28 2020
End Date
August 1 2026
Last Update
July 28 2025
Active Locations (1)
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1
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, United States, 28203