Moreno C, Closset J, Dugardeyn S, Baréa M, Mehdi A, Collignon L, Zalcman M, Baurain M, Le Moine O, Devière J
Department of Gastroenterology and Hepatopancreatology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
Endoscopy. 2008 May;40(5):406-13. doi: 10.1055/s-2007-995748.
Bariatric surgical treatments have been proven to induce long-term weight loss in morbidly obese patients, but complications are relatively frequent. We recently reported a first human multicenter trial assessing the safety, feasibility, and weight loss results of the Transoral Gastroplasty (TOGA) system (Satiety Inc., Palo Alto, CA) at 6 months. Here we report the 6-month results of the second phase of the pilot trial with the TOGA system, with technical improvements to the device.
Patients met established criteria for bariatric surgery. The TOGA system, a set of transoral endoscopically guided staplers, was used to create a stapled restrictive pouch along the lesser curvature of the stomach. Follow-up was at 1 week and at 1, 3, and 6 months. At 3 months, re-treatment consisting in additional distal restrictions was allowed if necessary.
Data were available for 11 patients in our center (7 female, mean age 44.2 years, mean body mass index 41.6). The procedure was completed safely in all patients. There were no serious adverse events. Mean excess weight loss was 19.2 %, 33.7 %, and 46.0 % at 1, 3, and 6 months, respectively. Average body mass index decreased from 41.6 before treatment to 33.1 at 6 months. Absolute mean weight loss was 9.9 kg, 17.5 kg, and 24.0 kg at 1, 3, and 6 months, respectively. A dramatic improvement in quality-of-life measures was observed in all patients.
This second pilot trial confirmed the feasibility and safety of transoral gastroplasty. The early results and technical improvements reported in the present study are encouraging in terms of safety, early weight loss, and quality of life, and clearly allowed multicenter trials, which are planned to start soon.
减肥手术已被证明可使病态肥胖患者长期减重，但并发症相对常见。我们最近报告了一项首次人体多中心试验，评估经口胃成形术（TOGA）系统（饱腹感公司，加利福尼亚州帕洛阿尔托）6个月时的安全性、可行性和减重效果。在此，我们报告该TOGA系统试点试验第二阶段的6个月结果，该设备有技术改进。
患者符合既定的减肥手术标准。TOGA系统是一套经口内镜引导的吻合器，用于沿胃小弯创建一个吻合器限制袋。随访时间为1周以及1、3和6个月。3个月时，如有必要，允许进行包括额外远端限制的再次治疗。
我们中心有11例患者的数据可用（7例女性，平均年龄44.2岁，平均体重指数41.6）。所有患者手术均安全完成。无严重不良事件。1、3和6个月时平均超重减轻分别为19.2%、33.7%和46.0%。平均体重指数从治疗前的41.6降至6个月时的33.1。1、3和6个月时绝对平均体重减轻分别为9.9千克、17.5千克和24.0千克。所有患者生活质量指标均有显著改善。
这项第二次试点试验证实了经口胃成形术的可行性和安全性。本研究报告的早期结果和技术改进在安全性、早期减重和生活质量方面令人鼓舞，并明确允许开展计划不久后启动的多中心试验。
