Protocol: RCR-003 // Website Patient Facing Material
Patient concerns about the invasiveness of weight loss has led to considerable interest in the minimally invasive field of endoscopic bariatric therapies. These include space-occupying intragastric balloons (IGBs) and the endoscopic sleeve gastroplasty (ESG). These stomach-targeting therapies affect appetite through non-hormonal, gastric sensorimotor influences on appetite by improving satiation and satiety.
Given the chronic, progressive, and relapsing nature of obesity, patients who underwent treatment with the temporary space-occupying IGB may experience weight regain and choose to pursue further weight loss strategies. The ESG is an option for patients after IGB wishing to avoid surgical and pharmacological weight loss. However, considering the overlapping mechanisms of appetite modification and weight loss from these therapies, it is not known if the clinical impact of ESG is as pronounced in patients previously treated with IGBs.
To address knowledge gaps in the safety and efficacy of ESG after IGB in patients with obesity, True You Weight Loss performed a retrospective evaluation of all patients who underwent ESG after IGB, comparing weight loss outcomes to a similar group of patients who did not have prior IGBs. This information will be critical to meaningfully counseling patients on the benefits and risks of undergoing an ESG after IGB.
As the highest-volume, non-academic endoscopic bariatric center in the United States, True You Weight Loss has a unique opportunity to evaluate the weight loss, safety, procedural findings, and predictive factors of total body weight loss of ESG after IGB in the community setting. The findings of this study will provide important information to the field of endoscopic bariatric therapies.
Methods: Retrospective review of prospectively collected data on 39 consecutive patients who underwent ESG after IGB at True You Weight Loss between August 2020 and September 2022. All patients were enrolled in a comprehensive lifestyle program with long-term nutritional support and monitoring. The primary study outcome is total body weight loss at 12 months. Secondary outcomes include total body weight loss and excess weight loss at 3, 6, and 9 months in addition to BMI at all timepoints. Safety, procedural characteristics, clinical response, number of visits after IGB and ESG, and predictors of weight loss.
Study status: study complete; findings published
