Miller Karl, Turró R, Greve J W, Bakker C M, Buchwald J N, Espinós J C
Bariatric Medical Unit, Wehrle Diakonissen Private Clinic, Salzburg, Austria.
Unidad de Endoscopia, Centro Médico Teknon, Barcelona, Catalonia, Spain.
Obes Surg. 2017 Feb;27(2):310-322. doi: 10.1007/s11695-016-2295-9.
Pose is an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported.
Subjects with classes I-II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months.
From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). Pose subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred.
In a randomized controlled trial at 12 months, pose-treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters.
clinicaltrials.gov identifier # NCT01843231.
Pose是一种腔内减肥干预措施，通过内镜将缝合锚钉置于胃底/胃体远端。对Pose的观察性研究表明其减肥效果安全有效。本文报告了一项随机对照试验的12个月结果，该试验比较了Pose与传统药物治疗后的体重减轻和饱腹感情况。
将I-II级肥胖受试者按3:1的比例随机分为Pose组或仅接受饮食/运动指导的对照组。Pose组受试者接受胃底和胃体远端缝合锚钉折叠术并接受饮食/运动咨询。在6个月和12个月时评估总体重减轻百分比（%TBWL）和超重减轻百分比（%EWL）。采用协方差分析（ANCOVA）分析12个月时的%TBWL。在6个月和12个月时评估饱腹感变化。
2013年11月至2014年7月，在三个中心将44名受试者（34名，77.3%为女性；平均年龄38.3±10.7岁；体重指数36.5±3.4kg/m²）随机分为Pose组（n = 34）或对照组（n = 10）。Pose手术平均时间为51.8±14.5分钟；Pose组受试者平均接受8.8±1.3次胃底折叠术和4.2±0.7次胃体远端折叠术。12个月时的总体重减轻情况：Pose组为13.0%（超重减轻45.0%），n = 30；对照组为5.3%（18.1%），n = 9；平均差异显著，为7.7%（95%CI 2.2, 13.2；p < 0.01）。Pose组受试者的饱腹感参数显著降低（p < 0.001）；对照组的热量摄入和饱腹感容积降低（p < 0.05）。未发生与器械或手术相关的严重不良事件。
在一项为期12个月的随机对照试验中，接受Pose治疗的受试者体重减轻显著大于仅接受饮食/运动指导的受试者。在6个月和12个月时，Pose组受试者的饱腹感参数显著降低。
clinicaltrials.gov标识符#NCT
