Stoma size critical to 12-month outcomes in endoscopic suturing for gastric bypass repair

Background: Roux-en-Y gastric bypass (RYGB) is the most frequently performed bariatric procedure. However, weight regain after RYGB is common and often associated with pouch and stoma dilation. Historically, revision surgery has a greater risk of morbidity and mortality than the primary procedure. Endoscopic repair appears to be a safer option; however, current knowledge is limited regarding the longer term outcomes. Our objective was to prospectively collect the 12-month post-RYGB outcomes data after repair of dilated gastric tissue with an incisionless tissue approximation system in an open-label, single-group study at 9 U.S. sites. Methods: Adults >= 2 years after RYGB, with weight regain and pouch and/or stoma dilation underwent tissue plication with an endolumenal anchoring system to tighten dilated gastric tissue. The outcomes were captured, with statistical modeling used to identify the predictors of success. Results: Of the 116 subjects, 112 (97%) had anchors successfully placed (mean 5.9 anchors/subject). The mean stoma diameter and pouch length after the procedure was 11.5 mm (50% reduction) and 3.3 cm (44% reduction), respectively. At 12 months after repair (n = 73), the mean weight loss and percentage of excess weight loss was 5.9 +/- 1.1 kg and 14.5% +/- 3.1%, respectively. Anchor presence was confirmed endoscopically in 61 (92%) of 66 patients at 1 year. Those with a dilated stoma (>12 mm) who had a postrepair diameter of <10 mm (n = 22, 30% of 66) had more than double the excess weight loss compared with the rest of the cohort (24% versus 10%, P = .03). No serious adverse events occurred. Conclusion: The 12-month outcomes have demonstrated the safety and durability of this method of gastric bypass repair. Aggressive reduction of stoma dilation was associated with superior weight loss. (Surg Obes Relat Dis 2012;8:282-287.) (C) 2012 American Society for Metabolic and Bariatric Surgery. All rights reserved.