Mucosal Impedance Sleeve Gastrectomy

Description

Obesity is a growing epidemic and bariatric surgery has been shown to be the most effective and efficient mean of achieving significant and sustainable weight loss in morbidly obese individuals. Studies have demonstrated that after LSG, between 5 and 30% of patients suffered from GERD, with a small subset of those patients (2.9 %) converting to another bariatric procedure (gastric bypass) because of debilitating GERD symptoms. The investigators propose this current study to examine mucosal impedance before and after sleeve gastrectomy using the novel mucosal impedance procedure, as well as assess quality of life and GERD symptoms parameters. In addition, this study will determine if the level of mucosal impedance pre-sleeve gastrectomy may predict the development of GERD post-surgery. Our Hypothesis is that sleeve gastrectomy is highly associated with the risk of developing new onset GERD. This is a prospective, comparative cohort study. A total of 15 obese patients (BMI ≥ 35) undergoing sleeve gastrectomy by choice will be recruited into the study from our bariatric and weight management program. An initial screening upper endoscopy will be performed as part of pre-bariatric evaluation, during which mucosal impedance will be performed with the consent of the patient. Patients with evidence of erosive esophagitis (LA grade A-D), Barrett's esophagus or eosinophilic esophagitis will be excluded from the study. As per surgical recommendation, PPI will be used for 6 months in all bariatric patients. Six months post-surgery, study patients will be re-evaluated by the GERD symptoms Checklist and SF 36. In addition, their new BMI will be documented. PPI will be held for at least 1 week and a 6 months post-surgical upper endoscopy will be performed to determine the presence or absence of erosive esophagitis and Barrett's esophagus. In addition, esophageal mucosal impedance will be reassessed.

Conditions

Gastroesophageal Reflux, Bariatric Surgery Candidate

Study Overview

Study Details

Study overview

Obesity is a growing epidemic and bariatric surgery has been shown to be the most effective and efficient mean of achieving significant and sustainable weight loss in morbidly obese individuals. Studies have demonstrated that after LSG, between 5 and 30% of patients suffered from GERD, with a small subset of those patients (2.9 %) converting to another bariatric procedure (gastric bypass) because of debilitating GERD symptoms. The investigators propose this current study to examine mucosal impedance before and after sleeve gastrectomy using the novel mucosal impedance procedure, as well as assess quality of life and GERD symptoms parameters. In addition, this study will determine if the level of mucosal impedance pre-sleeve gastrectomy may predict the development of GERD post-surgery. Our Hypothesis is that sleeve gastrectomy is highly associated with the risk of developing new onset GERD. This is a prospective, comparative cohort study. A total of 15 obese patients (BMI ≥ 35) undergoing sleeve gastrectomy by choice will be recruited into the study from our bariatric and weight management program. An initial screening upper endoscopy will be performed as part of pre-bariatric evaluation, during which mucosal impedance will be performed with the consent of the patient. Patients with evidence of erosive esophagitis (LA grade A-D), Barrett's esophagus or eosinophilic esophagitis will be excluded from the study. As per surgical recommendation, PPI will be used for 6 months in all bariatric patients. Six months post-surgery, study patients will be re-evaluated by the GERD symptoms Checklist and SF 36. In addition, their new BMI will be documented. PPI will be held for at least 1 week and a 6 months post-surgical upper endoscopy will be performed to determine the presence or absence of erosive esophagitis and Barrett's esophagus. In addition, esophageal mucosal impedance will be reassessed.

Assessment of Esophageal Mucosal Impedance Before and After Sleeve Gastrectomy

Mucosal Impedance Sleeve Gastrectomy

Condition
Gastroesophageal Reflux
Intervention / Treatment

-

Contacts and Locations

Cleveland

MetroHealth - Main Campus Medical Center, Cleveland, Ohio, United States, 44109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MetroHealth Medical Center,

Ronnie Fass, MD, PRINCIPAL_INVESTIGATOR, MetroHealth Medical Center

Study Record Dates

2025-01-15