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针对超级肥胖者的束带式与非束带式胃旁路手术前瞻性随机试验:早期结果

Prospective randomized trial of banded versus nonbanded gastric bypass for the super obese: early results.

作者信息

Bessler Marc, Daud Amna, Kim Teresa, DiGiorgi Mary

机构信息

Center for Obesity Surgery, Columbia University, New York-Presbyterian Hospital, New York, New York 10032, USA.

出版信息

Surg Obes Relat Dis. 2007 Jul-Aug;3(4):480-4; discussion 484-5. doi: 10.1016/j.soard.2007.01.010. Epub 2007 Jun 4.

Abstract

BACKGROUND

Banded gastric bypass has been reported to result in superior weight loss compared with standard nonbanded gastric bypass. However, an adequate comparison of these procedures has not yet been reported.

METHODS

A total of 90 patients were enrolled in this prospective randomized double-blind trial comparing banded and nonbanded open gastric bypass for the treatment of super obesity. The banding technique involved placement of a 1.5 x 5.5-cm polypropylene band around the proximal gastric pouch of a standard gastric bypass procedure using the technique of Capella. Chi-square testing and analysis of variance were performed to find any differences in patient characteristics (gender, age, and initial body mass index), percentage of excess weight lost at 6, 12, 24, and 36 months postoperatively, improvement or resolution of co-morbidities, and complications in the banded versus nonbanded gastric bypass groups.

RESULTS

As expected, no differences were present in the patient characteristics or incidence of co-morbidities between the banded (n = 46) and nonbanded (n = 44) groups. The body mass index, percentage of women, and mean age was 59.5 and 56.5 kg/m2, 64% and 73.8% (P = .09), and 40.6 +/- 7.4 and 42.6 +/- 7.2 years for the banded and nonbanded groups, respectively; all differences were nonsignificant. No significant differences were found in the resolution of co-morbidities. No significant difference was present in the percentage of excess weight loss at 6, 12, and 24 months (43.1% versus 24.7%, 64.0% versus 57.4%, and 64.2% versus 57.2%, respectively) postoperatively; however, the banded patients had achieved a significantly greater percentage of excess weight loss at 36 months (73.4% versus 57.7%; P <.05). The incidence of intolerance to meat and bread was greater in the banded patients. The overall number of complications was 12 (26%) in the banded and 13 (29.5%) in the nonbanded group, a nonsignficant difference. No band erosions had occurred at the last follow-up visit, and no patients in either group died.

CONCLUSION

These results suggest that although the initial weight loss was not significantly different between the 2 groups, the banded patients continued to lose weight for < or = 3 years. The polypropylene band appeared to be well tolerated. We plan longer follow-up to confirm the possibility of additional weight loss and the prevention of weight regain in the banded group, as well as to document any long-term band complications.

摘要

背景

据报道,与标准非捆绑式胃旁路手术相比,捆绑式胃旁路手术能带来更显著的体重减轻。然而,尚未有关于这两种手术的充分对比报道。

方法

本前瞻性随机双盲试验共纳入90例患者,比较捆绑式和非捆绑式开放式胃旁路手术治疗重度肥胖的效果。捆绑技术是采用卡佩拉技术,在标准胃旁路手术的近端胃囊周围放置一条1.5×5.5厘米的聚丙烯带。采用卡方检验和方差分析,以找出捆绑式和非捆绑式胃旁路手术组在患者特征(性别、年龄和初始体重指数)、术后6个月、12个月、24个月和36个月时多余体重减轻的百分比、合并症的改善或缓解情况以及并发症方面的差异。

结果

正如预期,捆绑式组(n = 46)和非捆绑式组(n = 44)在患者特征或合并症发生率方面没有差异。捆绑式组和非捆绑式组的体重指数、女性百分比和平均年龄分别为59.5和56.5 kg/m²、64%和73.8%(P = 0.09)、40.6±7.4岁和42.6±7.2岁;所有差异均无统计学意义。在合并症的缓解方面未发现显著差异。术后6个月、12个月和24个月时多余体重减轻的百分比无显著差异(分别为43.1%对24.7%、64.0%对57.4%、64.2%对57.2%);然而,捆绑式组患者在36个月时多余体重减轻的百分比显著更高(73.4%对57.7%;P < 0.05)。捆绑式组患者对肉类和面包不耐受的发生率更高。捆绑式组的并发症总数为12例(26%),非捆绑式组为13例(29.5%),差异无统计学意义。在最后一次随访时未发生带侵蚀,两组均无患者死亡。

结论

这些结果表明,尽管两组最初的体重减轻没有显著差异,但捆绑式组患者在≤3年的时间里持续减重。聚丙烯带似乎耐受性良好。我们计划进行更长时间的随访,以确认捆绑式组进一步减重和防止体重反弹的可能性,以及记录任何长期的带并发症。

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