Mucosal Impedance Sleeve Gastrectomy

Launched by METROHEALTH MEDICAL CENTER · Nov 14, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how a specific surgical procedure called sleeve gastrectomy affects patients' gastroesophageal reflux disease (GERD) symptoms and overall quality of life. Researchers want to understand whether measuring something called mucosal impedance—essentially how well the lining of the esophagus is functioning—can help predict if patients will develop GERD after surgery. The goal is to see if some patients are more at risk for GERD after the surgery, which can occur in a small percentage of people who undergo this weight-loss surgery.

To participate in this study, individuals must be between 18 and 80 years old, have a body mass index (BMI) of 35 or higher, and be scheduled for sleeve gastrectomy. Participants will undergo an initial screening procedure before their surgery, and then they will be monitored for six months afterward. This will include assessments of their GERD symptoms and quality of life, as well as follow-up procedures to check for any new issues related to their esophagus. It’s important to note that certain medical conditions, like existing esophagitis or previous stomach surgeries, may exclude individuals from joining the trial.

Gender

ALL

Eligibility 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.