Evaluating hiatal closure for treating early GERD
Efficacy Of Hiatal Closure For GERD
This study is testing if a new surgical method called hiatal closure can help people with early GERD feel better by fixing the problem with their esophagus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06280664 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of hiatal closure as a treatment for early Gastro-Esophageal Reflux Disease (GERD). The researchers hypothesize that this surgical approach can effectively address the underlying causes of GERD by repairing the anatomical defect and restoring the function of the lower esophageal sphincter. With the rise of minimally invasive laparoscopic techniques, the study seeks to explore the outcomes of hiatal closure alone, as opposed to traditional methods that often include fundoplication. The study will involve patients who meet specific eligibility criteria, focusing on those who are surgical candidates for hiatal closure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 50 with a BMI under 30 and specific pH testing results indicating GERD.
Not a fit: Patients who are outside the age range, have a higher BMI, or have more severe GERD symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and effective treatment option for patients suffering from early GERD.
How similar studies have performed: While traditional approaches to GERD treatment have been well-studied, the specific focus on hiatal closure alone is less explored, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 - 50 years * Able to provide informed consent * BMI \<30 * Hiatal defect \<4cm on esophagram * pH testing requirement: pH \<4 for \>5.5% * Surgical candidate for hiatal closure only Exclusion Criteria: * Vulnerable subjects (children, prisoners, pregnant women) will be excluded.
Where this trial is running
Chicago, Illinois
- The University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Yalini Vigneswaran, MD — University of Chicago
- Study coordinator: Yalini Vigneswaran, MD
- Email: yvigneswaran@bsd.uchicago.edu
- Phone: 773-702-6337
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.