Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy

N/AActive Not RecruitingNCT03705416

Johns Hopkins University250 enrolled

Overview

GERD is common in the obese population. Bariatric procedures are the mainstay of therapy for these patients. Bariatric procedures can be surgical (Roux-en-Y gastric bypass and Vertical sleeve gastrectomy) or endoscopic (endoscopic sleeve gastroplasty). The rate of GERD after either treatment is unknown as is the rate of silent reflux. The study primary objective is to assess the incidence rate of GERD in bariatric patients that undergo either therapy.

GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. GERD symptoms are common in the obese population with data showing weekly GERD symptoms in 34.6% and erosive esophagitis 26.9% in people with BMI \> 30 Kg/m2. Presently, bariatric procedures are the only sustainable method to address morbid obesity and its resulting comorbidities. There are endoscopic and surgical bariatric procedures. The natural history of GERD symptoms in this population after undergoing a bariatric treatment is scarce or conflicting. Moreover, silent or asymptomatic GERD prevalence has not been well established preoperatively. Evaluation and documentation of GERD may potentially change the planned bariatric procedure and avoid unnecessary additional surgeries or procedures to address symptomatic post-operative GERD. The investigators hypothesized that GERD is more prevalent in patients undergoing surgical bariatric procedures, specifically laparoscopic vertical sleeve gastrectomy (VSG). This multi-center, prospective, cohort study can potentially clarify current debatable data, based mostly on retrospective studies, and can help clinicians to select the most appropriate bariatric treatment for the patients. Most importantly, by selecting the best approach based on preoperative GERD studies it could prevent long term complications of GERD and further unnecessary procedures for the bariatric patient.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

GERD Obesity

Interventions

EndoscopyPROCEDURE

endoscopic suturing of stomach

SurgeryPROCEDURE

Vertical sleeve gastrectomy (VSG) surgical reduction of stomach, or (RYGBP) , or gastric bypass procedure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI ≥ 30 Kg/m2 * Patients scheduled to undergo a bariatric weight loss procedure (endoscopic or surgical) * Patients older than 18 years and younger than 75 years of age at time of consent * Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form * Patients willing and able to comply with study requirements for follow-up Exclusion Criteria: * Any patient with BMI \< 30 Kg/m2 * Patients treated with intragastric balloons. * Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD) * Esophageal, gastric or duodenal malignancy * Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist * Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy * Active fungal esophagitis * Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices * General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation * Pregnant or planning to become pregnant during period of study participation * Patient refuses or is unable to provide written informed consent * Prior bariatric treatment procedure * Prior surgical or endoscopic anti-reflux procedure

Locations (6)

Johns Hopkins University

Baltimore, Maryland, United States

Northwell Health

New Hyde Park, New York, United States

Weill Cornell

New York, New York, United States

Legacy Oregon Clinic

Portland, Oregon, United States

Outcomes

Primary Outcomes

Percentage of participants with GERD based on symptoms, and abnormal acid exposure time and/or reflux esophagitis

GERD symptoms, esophageal acid exposure time and/or esophagitis

Time frame: 1 year

Secondary Outcomes

Difference in BMI after the bariatric procedure

change in weight in Kg and height in m (BMI=Kg/m) before and after treatment

Time frame: 5 years

Reflux esophagitis

Incidence of GERD-related complications

Time frame: 5 years

GERD severity based on standardized Reflux Disease Questionnaire (RDQ)

GERD severity based on standardized Reflux Disease Questionnaire (RDQ) questionnaire (score 12-72; the greater the score, the greater the severity)

Time frame: 3,6,12,24,26,48, and 60 months post procedure

GERD severity as assessed by GERD-Health related quality of life (HRQL) score

GERD-Health related quality of life (HRQL) score (score 0-53; the greater the score,the worse the quality of life) will be used for this assessment

Time frame: 3,6,12,24,26,48, and 60 months post procedure

Percentage of participants on daily or twice daily PPI for GERD symptoms control, regardless of pH-monitoring results

Proportion of patients being treated with medication (PPI)

Time frame: 5 years

Percent of patients with abnormal esophageal acid exposure time > 6% defined by Bravo pH monitoring (96 hours)

Abnormal esophageal acid exposure time (AET)

Data from ClinicalTrials.gov

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