Recruiting

Mucosal Impedance

Sponsor:

MetroHealth Medical Center

Code:

NCT04166461

Conditions

Gastroesophageal Reflux

Bariatric Surgery Candidate

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Not application, observational study

Study Details

Brief summary:

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 ID

NCT04166461

Start date

Apr 21, 2021

Status verified date

Feb, 2024

Completion date

Jan 15, 2025

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

Not application, observational study

Not application, observational study

Primary outcome measure

  • Development of gastroesophageal reflux disease after sleeve gastrectomy [ Time Frame: Time of recruitment to 6 months after sleeve gastrectomy ]

Central Contacts and Locations

Central contacts

Locations

MetroHealth - Main Campus Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

More Information

Sponsor

MetroHealth Medical Center

Last update posted

Feb 20, 2024

Last verified

Feb, 2024

Keywords

  • Mucosal impedance
  • Sleeve gastrectomy
  • GERD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MetroHealth Medical Center on 2024-02-20.