Phillips Edward, Ponce Jaime, Cunneen Scott A, Bhoyrul Sunil, Gomez Eddie, Ikramuddin Sayeed, Jacobs Moises, Kipnes Mark, Martin Louis, Marema Robert T, Pilcher John, Rosenthal Raul, Rubenstein Richard, Teixeira Julio, Trus Thadeus, Zundel Natan
Cedars-Sinai Medical Center, Los Angeles, California, USA.
Surg Obes Relat Dis. 2009 Sep-Oct;5(5):588-97. doi: 10.1016/j.soard.2008.12.007. Epub 2009 Jan 18.
The effectiveness and safety of bariatric surgery using laparoscopic adjustable gastric bands have been demonstrated in numerous published studies. We present the results of the first U.S. multicenter trial of the Realize adjustable gastric band, a laparoscopic adjustable gastric band previously available only outside the United States as the Swedish adjustable gastric band.
A total of 405 morbidly obese patients were screened at 12 different centers from May to November 2003 to participate in a prospective, single-arm study of the safety and effectiveness of the laparoscopically implanted Realize band. Changes in excess body weight, the parameters of diabetes and dyslipidemia, and the incidence of complications were assessed at 3 years of follow-up.
Of the 405 patients, 276 (78.3% women and 61.2% white) qualified for the study. The average age was 38.6 + or - 9.4 years (range 18-61), and the preoperative body mass index was 44.5 + or - 4.7 kg/m(2). The mean hospital stay was 1.2 + or - 1.3 days. At 3 years, the average excess weight loss was 41.1% + or - 25.1% or a decrease in the body mass index of 8.2 kg/m(2) (18.6%) (P < .001). In diabetic patients with a baseline elevated hemoglobin A(1)c level, the level decreased by 1% (P < .001). The total cholesterol, low-density lipoprotein cholesterol, and triglycerides decreased by 9%, 16%, and 50%, respectively (P < .001), and the high-density lipoprotein cholesterol increased by 25% (P < .001) in patients with abnormal baseline values. One patient required conversion to an open surgical technique. No 30-day mortality occurred. The complication frequencies were generally low and included esophageal dysmotility in 0.4%, late balloon failure in 0.4%, band erosion in 0.4%, slippage in 3.3%, esophageal dilation in 3.3%, pouch dilation in 3.6%, catheter kinking in 1.1%, port displacement in 2.5%, and port disconnection in 4.3%. Reoperations were required in 15.2% of the patients and involved 2 band replacements, 9 band revisions, 5 port replacements, 22 port revisions, and 4 explants.
The results of our study have shown that the Realize adjustable gastric band is safe and effective in a diverse U.S. population of morbidly obese patients. Significant weight loss was achieved throughout the 3 years of follow-up, with corresponding improvements in the indicators of diabetes and dyslipidemia.
众多已发表的研究证实了使用腹腔镜可调节胃束带进行减肥手术的有效性和安全性。我们公布了美国首次对Realize可调节胃束带进行的多中心试验结果，该腹腔镜可调节胃束带此前仅在美国以外地区作为瑞典可调节胃束带使用。
2003年5月至11月期间，在12个不同中心对总共405例病态肥胖患者进行了筛查，以参与一项关于腹腔镜植入Realize束带安全性和有效性的前瞻性单臂研究。在随访3年时评估超重体重的变化、糖尿病和血脂异常参数以及并发症的发生率。
405例患者中，276例（78.3%为女性，61.2%为白人）符合研究条件。平均年龄为38.6±9.4岁（范围18 - 61岁），术前体重指数为44.5±4.7kg/m²。平均住院时间为1.2±1.3天。3年时，平均超重体重减轻41.1%±25.1%，或体重指数下降8.2kg/m²（18.6%）（P <.001）。在基线糖化血红蛋白水平升高的糖尿病患者中，该水平下降了1%（P <.001）。基线值异常的患者中，总胆固醇、低密度脂蛋白胆固醇和甘油三酯分别下降了9%、16%和50%（P <.001），高密度脂蛋白胆固醇升高了25%（P <.001）。1例患者需要转为开放手术技术。未发生30天内死亡。并发症发生率总体较低，包括食管运动障碍0.4%、后期球囊故障0.4%、束带侵蚀0.4%、滑脱3.3%、食管扩张3.3%、胃囊扩张3.6%、导管扭结1.1%、端口移位2.5%和端口断开4.3%。15.2%的患者需要再次手术，包括2次束带更换、9次束带修复、5次端口更换、22次端口修复和4次取出。
我们的研究结果表明，Realize可调节胃束带在不同的美国病态肥胖患者群体中是安全有效的。在整个3年的随访期间实现了显著的体重减轻，同时糖尿病和血脂异常指标也相应改善。
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