Examining mucosal impedance in patients undergoing sleeve gastrectomy
Assessment of Esophageal Mucosal Impedance Before and After Sleeve Gastrectomy
This study is testing if measuring the mucosal impedance in obese patients before and after sleeve gastrectomy can help predict if they will develop GERD and how it affects their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | MetroHealth Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04166461 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate mucosal impedance levels in obese patients before and after undergoing sleeve gastrectomy, a common bariatric surgery. The study will assess the relationship between mucosal impedance and the development of gastroesophageal reflux disease (GERD) post-surgery, as well as evaluate quality of life and GERD symptoms. A total of 15 patients with a BMI of 35 or higher, who are scheduled for sleeve gastrectomy and have no signs of esophagitis, will be enrolled. The hypothesis is that higher mucosal impedance pre-surgery may predict the onset of GERD after the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are obese adults aged 18 to 80 with a BMI of 35 or higher, scheduled for sleeve gastrectomy and without esophagitis.
Not a fit: Patients with a history of GERD, esophageal disorders, or previous bariatric surgery are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for developing GERD after sleeve gastrectomy, potentially guiding preoperative assessments and improving patient outcomes.
How similar studies have performed: While studies have shown varying effects of sleeve gastrectomy on GERD, this specific approach using mucosal impedance is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ambulatory male or female (non-pregnant) and is 18-80 years old at the time of enrollment. * Adults with BMI 35 ≥ kg/m2 * Patients scheduled for sleeve gastrectomy * Patients with no presence of esophagitis on screening upper endoscopy will be recruited to pursue 6mo- post-op upper endoscopy. Exclusion Criteria: * Age \< 18 or \> 80 years old * Female patients cannot be pregnant or agree to avoid pregnancy during study period. * History of GERD, erosive esophagitis, esophageal stricture, Barrett's esophagus or esophageal varices * History of a major motility disorder: achalasia, diffuse esophageal spasm, jackhammer esophagus, esophagogastric junction outflow obstruction, and absent peristalsis. * History of Eosinophilic Esophagitis * History of bariatric surgery or other upper gastrointestinal surgery * History of Scleroderma * PPI use prior to bariatric procedure * History of severe psychiatric disorder, including suicidal ideation or admission to psychiatric institution. * Negative upper endoscopy during pre-LSG evaluation for esophagitis, Barrett's esophagus, peptic stricture or eosinophilic esophagitis.
Where this trial is running
Cleveland, Ohio
- MetroHealth - Main Campus Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ronnie Fass, MD — MetroHealth Medical Center
- Study coordinator: Ronnie Fass, MD
- Email: rfass@metrohealth.org
- Phone: 2167783145
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.