Incisionless revision of post-Roux-en-Y bypass stomal and pouch dilation: multicenter registry results.
Surgical revision for weight regain after Roux-en-Y gastric bypass (RYGB) has been tempered by the high complication rates associated with standard approaches. Endoluminal revision of stoma and pouch dilation should intuitively confer a better risk profile. However, questions of clinical safety, durability, and weight loss need to be answered. We report our multicenter intraoperative experience and postoperative follow-up to date using the Incisionless Operating Platform for this patient subset. The patients who had regained significant weight >or=2 years after RYGB after losing >or=50% of excess body weight after RYGB were endoscopically screened for stomal and/or pouch dilation. Qualified patients underwent incisionless revision using the Incisionless Operating Platform to reduce the stoma and pouch size by placing anchors to create tissue plications. Data on the safety, intraoperative performance, postoperative weight loss, and anchor durability were recorded to date as a part of 2 years of postoperative follow-up. A total of 116 consecutive patients were prospectively studied. Anchors were successfully placed in 112 (97%) of 116 patients, with an average intraoperative stoma diameter and pouch length reduction of 50% and 44%, respectively. The operating room time averaged 87 minutes. No significant complications occurred. At 6 months after the procedure (n = 96), an average of 32% of weight regain that had occurred after RYGB had been lost. The percentage of excess weight loss averaged 18%. The 12-month esophagogastroduodenoscopy results confirmed the presence of the anchors and durable tissue folds. Incisionless revision of stoma and pouch dilation using the Incisionless Operating Platform can be performed safely. The data to date have demonstrated mild-to-moderate weight loss, and the early 12-month endoscopic images have confirmed anchor durability. Patients were actively followed up to document the long-term durability of this intervention in the entire patient subset.