RESUMO
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.
