Predicting gastroesophageal reflux after sleeve gastrectomy
Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)
This study is trying to find out what factors might lead to gastroesophageal reflux disease (GERD) in people after they have sleeve gastrectomy surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Orlando, Florida and 1 other locations) |
| Trial ID | NCT04411823 on ClinicalTrials.gov |
What this trial studies
This study aims to identify predictors for gastroesophageal reflux disease (GERD) following sleeve gastrectomy. Participants will undergo an upper endoscopy with the EndoFLIP device before the surgery to gather data on various parameters. A follow-up endoscopy will be conducted at six months post-surgery if clinically indicated, along with questionnaires over a five-year period to assess outcomes. The goal is to develop a predictive model for GERD after the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with a BMI of 30 or greater who can consent to the procedure.
Not a fit: Patients with severe esophagitis, Barrett's esophagus, major motility disorders, or previous stomach surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for GERD after sleeve gastrectomy, leading to better management and outcomes.
How similar studies have performed: Other studies have explored similar predictive models for post-surgical complications, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients \> 18 years * BMI 30 or greater kg/m2 * Participants can give a consent to the procedure * Participants have no contraindications to LSG (gastric ulceration) Exclusion Criteria: * Participants who have LA grade C or D esophagitis, Barrett mucosa or peptic stricture. * Patients who have evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis) * Patients with hiatal hernia \> 3 cm * Patients with previous esophageal or stomach surgery
Where this trial is running
Orlando, Florida and 1 other locations
- Orlando Health — Orlando, Florida, United States (Active_not_recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Omar Ghanem, MD — Mayo Clinic
- Study coordinator: Elizabeth Lemke
- Email: Lemke.Elizabeth@mayo.edu
- Phone: 5072663317
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.