Predicting gastroesophageal reflux after sleeve gastrectomy
Official title: Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)
Run by Mayo Clinic · NCT04411823 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Orlando, Florida and 1 other locations) |
| Status | Recruiting |
| Started | February 1, 2021 |
| Main results expected | October 2028 |
| Study ends | October 2028 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT04411823 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years with a BMI of 30 or greater who can consent to the procedure.
✕Probably not a fit
Patients with severe esophagitis, Barrett's esophagus, major motility disorders, or previous stomach surgeries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have explored similar predictive models for post-surgical complications, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
-
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting -
Orlando Health
Orlando, Florida, United States Active not recruiting
Study contacts
- Principal investigator: Omar Ghanem, MD — Mayo Clinic
- Study coordinator: Elizabeth Lemke
- Email: Lemke.Elizabeth@mayo.edu
- Phone: 5072663317
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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15-year outcomes after sleeve gastrectomy in France
This study looks at how people who had sleeve gastrectomy have fared over 15 years to see long-term weight changes and health effects.
-
POEM vs Heller myotomy with Dor fundoplication for achalasia
This trial tests POEM against laparoscopic Heller myotomy with Dor fundoplication to see which procedure better helps adults with achalasia.
-
Extra daily iron after sleeve gastrectomy to prevent anemia
This study tests whether taking an extra daily iron pill plus a multivitamin prevents iron deficiency anemia in adults during the six months after sleeve gastrectomy compared with taking a multivitamin alone.
-
Foot reflexology to reduce nausea after sleeve gastrectomy
This will try foot reflexology to see if it reduces nausea and vomiting in adults after sleeve gastrectomy.
-
Hydrotalcite (Talcid) for relief of rebound acid symptoms after stopping long-term PPI therapy
We are trying hydrotalcite (Talcid) to see if it relieves rebound acid symptoms in adults who have stopped long-term PPI treatment.
-
Digestion and gut function after bariatric surgery
This project will test how digestion — including enzymes, bile acids, pH, and transit time — works in adults with obesity and in people at least one year after Roux‑en‑Y or sleeve gastrectomy by collecting intestinal samples and using a swallowable sensor capsule.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.