Esophagogastric Junction Distensibility During Hiatal Hernia Repair
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 25, 2020
Trial Information
Current as of July 05, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how repairing a hiatal hernia affects the esophagogastric junction (EGJ), which is the area where the esophagus meets the stomach. The researchers want to see if the surgery, along with a procedure called fundoplication (which helps prevent acid reflux), changes how flexible this junction is. They will also look into whether changes in the junction's flexibility relate to patients' quality of life concerning gastroesophageal reflux disease (GERD) and any swallowing difficulties they might have.
To participate in this trial, patients need to be adults aged 18 or older who are scheduled for elective surgery to repair a hiatal hernia (types I-IV) and receive fundoplication. However, patients with certain conditions, such as previous surgeries on the hiatal hernia or specific esophageal disorders, may not be eligible. Participants can expect to undergo some assessments before and after their surgery to evaluate the results, and their experiences with GERD and swallowing will be part of the study. This research aims to improve understanding of how surgical treatments affect patients' everyday lives.
Gender
ALL
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) 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
- • Connective tissue diseases such as scleroderma or lupus
- • Diameter measurements less than 5 mm as the EF-325N catheter is not suitable
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charlotte, North Carolina, United States
Patients applied
Trial Officials
Paul D Colavita, MD
Principal Investigator
Wake Forest University Health Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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