Division of Gastroenterology, Brigham & Women's Hospital, Boston, Massachusetts.
Loyola University Medical Center, Maywood, Illinois.
Gastroenterology. 2013 Jul;145(1):129-137.e3. doi: 10.1053/j.gastro.2013.04.002. Epub 2013 Apr 5.
BACKGROUND & AIMS: Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe).
Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed.
Subjects who received TORe had a significantly greater mean percentage weight loss from baseline (3.5%; 95% confidence interval, 1.8%-5.3%) than controls (0.4%; 95% confidence interval, 2.3% weight gain to 3.0% weight loss) (P = .021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9% and 0.2%, respectively; P = .014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (P = .019). The TORe group had reduced systolic and diastolic blood pressure (P < .001) and a trend toward improved metabolic indices. In addition, 85% of the TORe group reported compliance with the healthy lifestyle eating program, compared with 53.8% of controls; 83% of TORe subjects said they would undergo the procedure again, and 78% said they would recommend the procedure to a friend. The groups had similar frequencies of adverse events.
A multicenter randomized trial provides Level I evidence that TORe reduces weight regain after RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results. ClinicalTrials.gov identifier: NCT00394212.
Roux-en-Y 胃旁路术后（RYGB）体重反弹或减重不足较为常见。这部分归因于胃肠吻合口扩张（GJ），其减小了 RYGB 的限制能力。正在探索经内镜 GJ 缩小术作为手术修正的替代方法。我们进行了一项随机、盲法、假手术对照试验，以评估经口吻合口缩小术（TORe）后的减重效果。
RYGB 术后体重反弹或减重不足且 GJ 直径大于 2cm 的患者被随机分配至接受 TORe（n=50）或假手术（对照组，n=27）的两组。术中表现、安全性、减重效果和临床结局得到评估。
接受 TORe 的患者体重较基线下降的平均百分比明显更高（3.5%；95%置信区间，1.8%-5.3%），对照组为 0.4%（95%置信区间，2.3%体重增加到 3.0%体重减轻）（P=0.021），采用意向性治疗分析的最后一次观察值结转。按治疗分析，TORe 组的平均体重下降百分比也高于对照组（分别为 3.9%和 0.2%；P=0.014）。TORe 组 96%的患者和对照组 78%的患者实现了体重减轻或稳定（P=0.019）。TORe 组收缩压和舒张压降低（P<0.001），代谢指标有改善趋势。此外，85%的 TORe 组患者报告遵守健康生活方式饮食计划，而对照组为 53.8%；83%的 TORe 患者表示愿意再次接受该手术，78%的患者表示愿意向朋友推荐该手术。两组不良事件发生率相似。
一项多中心随机试验提供了 I 级证据，证明 TORe 可减少 RYGB 后的体重反弹。这些结果是使用表面抽吸式设备实现的；使用更新的全层缝合设备可能会实现更大程度的减重。TORe 是避免体重反弹的一种方法；需要采用饮食咨询和行为改变的长期多学科方法才能获得长期效果。临床试验.gov 标识符：NCT00394212。
