Pilot study evaluating technical feasibility and early outcomes of second-generation endosurgical platform for treatment of weight regain after gastric bypass surgery

Background: For some gastric bypass patients, dilation of the gastrojejunal anastomosis (GJA) and/or gastric pouch is believed to contribute to weight regain. The present study had 2 objectives: (1) to assess the technical feasibility and safety of a novel endoscopic procedure called revision obesity surgery endoscopic (ROSE) using a second-generation, prototype endoscopic operating system that creates tissue plications to reduce the diameter of the GJA and the size of the gastric pouch and (2) to assess the early outcomes regarding weight loss at a university hospital in the United States. Methods: This was a prospective study of 5 patients who had regained a mean of 14.7 ka, after gastric bypass with a dilated pouch and GJA on screening endoscopy. The gastric pouch and the GJA were measured before and after the procedure. The patients were followed up for a minimum of 3 months after the procedure. Weight changes were recorded. Results: Technical success was achieved in all 5 patients (100%). The mean weight loss in the successful cases was 7.8 kg at 3 months. No major complications developed. Conclusion: The results of our study have shown that the ROSE procedure using this second-generation prototype endoscopic operating system is technically feasible and appears safe. Our preliminary results suggest that the ROSE procedure is effective in reducing the size of both the GJA and the gastric pouch and could therefore be an alternative therapy for weight regain in postgastric bypass patients. (Surg Obes Relat Dis 2009;5:450-454.) (C) 2009 American Society for Metabolic and Bariatric Surgery. All rights reserved.