Using EndoFLIP to Enhance Quality of Life for GERD and Hiatal Hernia Patients
Can EndoFLIP Improve Quality of Life Before and After Fundoplication?
NA · Queen's University · NCT06159972
This study is testing whether using a new tool during surgery can help improve the quality of life for people with GERD and hiatal hernias.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen's University (other) |
| Locations | 1 site (Kingston, Ontario) |
| Trial ID | NCT06159972 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a new surgical instrument called EndoFLIP during fundoplication surgery for patients suffering from gastroesophageal reflux disease (GERD) and hiatal hernias. The instrument allows surgeons to take precise measurements during the operation, which will be compared to quality of life scores derived from patient questionnaires. The goal is to improve surgical outcomes and patient satisfaction by utilizing these measurements to guide the surgical process. The study aims to address the challenges faced by patients who have not responded to medication and may be hesitant to undergo traditional preoperative assessments.
Who should consider this trial
Good fit: Ideal candidates are adult patients being evaluated for GERD and/or symptomatic hiatal hernia who are scheduled for fundoplication.
Not a fit: Patients with a history of previous hiatal hernia repair, fundoplication, esophagectomy, or gastrectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients undergoing surgery for GERD and hiatal hernias.
How similar studies have performed: While the use of EndoFLIP is a novel approach in this context, similar studies have shown promising results in improving surgical outcomes in other gastrointestinal procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients undergoing workup for gastroesophageal reflux disease (GERD) and/or symptomatic hiatal hernia who undergo fundoplication AND who undergo fundoplication Exclusion Criteria: * Those with a previous history of hiatal hernia repair, fundoplication, esophagectomy, or gastrectomy * Inability to provide consent
Where this trial is running
Kingston, Ontario
- KHSC — Kingston, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Wiley Chung, MD MHPE — Queen's University
- Study coordinator: Nader M Hanna, MBBS, MSc
- Email: nader.hanna@queensu.ca
- Phone: (613) 549-6666
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: GERD, Hiatal Hernia