Assessing esophagogastric junction distensibility during hiatal hernia repair
Esophagogastric Junction Distensibility During Hiatal Hernia Repair
NA · Wake Forest University Health Sciences · NCT04450628
This study is trying to see how repairing a hiatal hernia affects the flexibility of the esophagogastric junction in patients having surgery for acid reflux and how it relates to their quality of life and swallowing difficulties.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT04450628 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) using the EndoFLIP system. Patients referred for antireflux surgery will undergo a series of preoperative assessments, including esophagogastroduodenoscopy and high-resolution esophageal manometry. The study aims to correlate EGJ distensibility measurements with quality of life and dysphagia scores related to gastroesophageal reflux disease (GERD). Intraoperative measurements will provide insights into the effectiveness of the surgical interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing elective hiatal hernia repair and fundoplication without spastic esophageal disorders.
Not a fit: Patients with redo hiatal hernia repairs, emergent repairs, or contraindications to surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and quality of life for patients with hiatal hernias and GERD.
How similar studies have performed: Previous studies using similar methodologies have shown promise in understanding esophageal function and improving surgical techniques.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlotte, North Carolina
- Atrium Health - Carolinas Medical Center — Charlotte, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Paul D Colavita, MD — Wake Forest University Health Sciences
- Study coordinator: Greg T Scarola, MS
- Email: Gregory.Scarola@atriumhealth.org
- Phone: 704-355-5379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophagogastric Junction Distensibility, Hiatal Hernia, EndoFLIP, Distensibility of the esophagogastric junction, Gastroesophageal Reflux Disease-Health Related Quality of Life survey, Mayo Dysphagia Questionnaire