Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy (ROSE)

Johns Hopkins University

Status: Active, not recruiting

Conditions: Obesity; GERD

Treatments: Procedure: Surgery; Procedure: Endoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT03705416

IRB00186052

The ROSE study (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Endoscopic sleeve gastroplasty

Description:

All obese patients who will be undergoing an endoscopic sleeve gastroplasty (ESG). As part of the standard of care this patients will have a preoperative gastroscopy with wireless pH monitoring. Then after the endoscopic sleeve gastroplasty patients will be followed up regarding GERD symptoms for 5 years. As part of the standard of care a follow up endoscopy will be done at year 1 and wireless pH monitoring will be performed

Treatment:

Procedure: Endoscopy

Surgery (VSG or RYGBP)

Description:

All obese patients who will be undergoing either a vertical sleeve gastrectomy or a Roux-en-Y gastric bypass. As part of the standard of care this patients will have a preoperative gastroscopy with wireless pH monitoring. Then after the surgical procedure patients will be followed up regarding GERD symptoms for 5 years. As part of the standard of care a follow up endoscopy will be done at year 1 and wireless pH monitoring will be performed

Treatment:

Procedure: Surgery