NCT03705416

Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy

Reflux in the Obese Undergoing Surgery or Endoscopy (ROSE) Previously: Gastroesophageal Reflux Disease (GERD) in Bariatric Patients

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• GERD
• Obesity

Interventions

Type	Name	Description
PROCEDURE	Endoscopy	endoscopic suturing of stomach
PROCEDURE	Surgery	Vertical sleeve gastrectomy (VSG) surgical reduction of stomach, or (RYGBP) , or gastric bypass procedure

Timeline

• Start date: 2019-03-30
• Primary completion: 2026-06-01
• Completion: 2028-03-30
• First posted: 2018-10-15
• Last updated: 2025-12-18

Locations

6 sites across 1 country: United States