Abstract
Weight regain following Roux-en-Y gastric bypass (RYGB) is a growing problem. Transoral Outlet Reduction (TORe) is a commonly performed procedure to address this condition, and the aim of this study is to assess its long-term efficacy. Study Design: A retrospective review of prospectively collected data on RYGB patients who underwent TORe for weight regain. Technique: TORe was performed using a full-thickness endoscopic suturing device. The GJA was ablated using argon plasma coagulation (APC). Stitches were placed around the GJA to reduce its size. Primary Outcome: Percent total weight loss (%TWL) at 7 years following TORe. Secondary Outcomes: Procedure details, safety profile classified using the ASGE lexicon, number needed to treat (NNT) to stop weight regain and predictors of %TWL at 7 years following TORe. A total of 443 RYGB patients underwent TORe and were included in the study. Baseline age, weight and BMI were 49±11 years, 116.9±28.4 kg and 41.8±10.5 kg/m2. On average, the patients were 7±3 years post-RYGB and had regained 43.9±26.3% of maximal weight lost. Pre-TORe GJA size was 25.0±6.4 mm, which decreased to 7.2±2.6 mm after TORe. Primary Outcomes: Patients lost 9.5±9.5 kg, 8.6±11.7, 10.5±17.5 kg and 10.1±16.0 kg at 1, 3, 5 and 7 years, respectively (p<0.01 for all). This corresponded to 7.5±6.6%, 6.9±8.9%, 7.5±14.4% and 8.4±12.8% TWL at 1, 3, 5 and 7 years with follow-up rates of 86%, 94%, 86% and 72% of patients eligible for follow-up at these time points, respectively (Figure 1). Secondary Outcomes: 80.3%, 16.1% and 3.6% of the cases were performed using single pursestring, interrupted, and double pursestring suture patterns, respectively, with an average of 10±4 stitches (bites) per GJA. Pouch reinforcement suturing was performed in 62%, with an average of 3±2 stitches per pouch. There were no severe adverse events. At 7 years, 32% of the patients had an additional weight loss therapy including pharmacotherapy (18%), repeat TORe (10%), and surgical revision (4%). The NNT to stop weight regain at 7 years was 1.3. Amount of weight loss at 1 year (β=0.67, p=0.03) was a predictor of %TWL at 7 years after controlling for age, sex, weight regain and the use of adjunctive therapy. TORe appears safe, effective and durable at treating weight regain following RYGB, with a NNT of 1.3. The amount of weight loss at 1 year predicts 7-year efficacy and may help direct use of adjunctive therapy.
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