Mucosal Impedance Sleeve Gastrectomy

  • STATUS
    Recruiting
  • days left to enroll
    85
  • participants needed
    40
  • sponsor
    MetroHealth Medical Center
Updated on 29 December 2021

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.

Description

Rationale/Significance:

Obesity is a growing epidemic problem around the world. World Health Organization (WHO) defines obesity as a body mass index (BMI) over 30 Kg/m2 and it is estimated that 10% of the world's population is obese. Associated with obesity are health conditions that carry significant morbidity and mortality, including cardiovascular disease, osteoarthritis, diabetes, cancer (breast, colon and endometrial) and gastroesophageal reflux disease (GERD). Bariatric surgery has been shown to be the most effective and efficient mean of achieving significant and sustainable weight loss in morbidly obese individuals.

As part of their limited GI workup, candidates for bariatric surgery usually undergo only an upper endoscopy prior to surgery. However, no studies are preferred to assess the degree of esophageal acid exposure in patients with normal endoscopy who are candidates for LSG. In addition, there is no routine assessment of patients post LSG for the development of GERD.

The effect of laparoscopic sleeve gastrectomy (LSG) on GERD has been equivocal with low-quality evidence suggesting both improvement and worsening of reflux after surgery. 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.

As part of their limited GI workup, candidates for bariatric surgery usually undergo only an upper endoscopy prior to surgery. Currently there is no routine formal (endoscopic or pH) assessment of patients after gastric weight loss surgery for the development of GERD. The effect of laparoscopic sleeve gastrectomy (LSG) on GERD has been equivocal with low-quality evidence from various studies suggesting both improvement and worsening of reflux after surgery.

The main purpose of this study is to evaluate whether GERD develops after LSG and to examine the esophagus after LSG for the possible development of acid reflux both endoscopically (visible by camera view) and on a cellular level by obtaining mucosal impedance. Mucosal impedance (MI) is a measurement that can evaluate if the structure of the esophageal tissue is normal or abnormal. MI is performed using an FDA approved endoscopic tool called "Mucosal Integrity Conductivity Test System" (Diversatek). The MI system software uses the collected data to determine if there is evidence of GERD.

Objective

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.

Primary aim

  • To determine the development of GERD after sleeve gastrectomy by measuring esophageal mucosal impedance pre and post-surgery.

Secondary aim

  • To determine the degree of GERD development post sleeve gastrectomy
  • To determine any effect on quality of life post-sleeve gastrectomy

Details
Condition Gastroesophageal Reflux, Bariatric Surgery Candidate
Treatment Not application, observational study
Clinical Study IdentifierNCT04166461
SponsorMetroHealth Medical Center
Last Modified on29 December 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note