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SleevePass:一项比较腹腔镜袖状胃切除术和胃旁路术治疗病态肥胖的随机前瞻性多中心研究:初步结果。

SLEEVEPASS: a randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results.

机构信息

Department of Surgery, Turku University Hospital, PL 52, 20521 Turku, Finland.

出版信息

Surg Endosc. 2012 Sep;26(9):2521-6. doi: 10.1007/s00464-012-2225-4. Epub 2012 Apr 5.


DOI:10.1007/s00464-012-2225-4
PMID:22476829
Abstract

BACKGROUND: The long-term efficacy of laparoscopic Roux-en-Y gastric bypass (RYGB) in the treatment of morbid obesity has been demonstrated. Laparoscopic sleeve gastrectomy (SG) as a single procedure has shown promising short-term results, but the long-term efficacy of SG has not yet been demonstrated. The aim of this study was to determine the preliminary 30-day morbidity and mortality of RYGB and SG in a prospective multicenter randomized setting. METHODS: A total of 240 morbidly obese (BMI = 35-66 kg/m²) patients evaluated by a multidisciplinary team were randomized to undergo either RYGB or SG. There were 117 patients in the RYGB group and 121 in the SG group; two patients had to be excluded after randomization. Both study groups were comparable regarding age, gender, BMI, and comorbidities. RESULTS: There was no 30-day mortality. The median operating time was significantly shorter in the SG group (66 min vs. 94 min, p < 0.001). All complications were recorded thoroughly. There were 7 (5.8 %) major complications following SG and 11 (9.4 %) after RYGB (p = 0.292). Nine (7.4 %) SG patients and 20 (17.1 %) RYGB patients had minor complications (p = 0.023). The overall morbidity was 13.2 % after SG and 26.5 % after RYGB (p = 0.010). There were three (2.5 %) early reoperations after SG and four (3.3 %) after RYGB (p = 0.719). CONCLUSIONS: At 30-day analysis SG is associated with a shorter operating time and fewer early minor complications compared to RYGB. There were no significant differences in major complications or early reoperations. Long-term follow-up is required to determine the effect on weight loss, resolution of obesity-related comorbidities, and improvement of quality of life.

摘要

背景:腹腔镜 Roux-en-Y 胃旁路术(RYGB)治疗病态肥胖症的长期疗效已得到证实。腹腔镜袖状胃切除术(SG)作为单一手术已显示出有前途的短期效果,但 SG 的长期疗效尚未得到证实。本研究旨在确定前瞻性多中心随机分组中 RYGB 和 SG 的初步 30 天发病率和死亡率。

方法:由多学科团队评估的 240 名病态肥胖症患者(BMI=35-66kg/m²)被随机分为 RYGB 组或 SG 组。RYGB 组 117 例,SG 组 121 例;随机分组后有 2 例患者需要排除。两组患者在年龄、性别、BMI 和合并症方面具有可比性。

结果:无 30 天死亡。SG 组的中位手术时间明显缩短(66min 比 94min,p<0.001)。全面记录了所有并发症。SG 后有 7 例(5.8%)严重并发症,RYGB 后有 11 例(9.4%)(p=0.292)。SG 患者中有 9 例(7.4%)和 RYGB 患者中有 20 例(17.1%)有轻微并发症(p=0.023)。SG 后总发病率为 13.2%,RYGB 后为 26.5%(p=0.010)。SG 后有 3 例(2.5%)早期再次手术,RYGB 后有 4 例(3.3%)(p=0.719)。

结论:在 30 天分析中,与 RYGB 相比,SG 具有更短的手术时间和更少的早期轻微并发症。严重并发症或早期再次手术无显著差异。需要进行长期随访以确定对体重减轻、肥胖相关合并症的解决以及生活质量的改善的影响。

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本文引用的文献

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N Engl J Med. 2004-12-23

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