Murphy Rinki, Clarke Michael G, Evennett Nicholas J, John Robinson S, Lee Humphreys M, Hammodat Hisham, Jones Bronwen, Kim David D, Cutfield Richard, Johnson Malcolm H, Plank Lindsay D, Booth Michael W C
Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.
Obes Surg. 2018 Feb;28(2):293-302. doi: 10.1007/s11695-017-2872-6.
There are very few randomised, blinded trials comparing laparoscopic sleeve gastrectomy (LSG) versus laparoscopic Roux-en-Y gastric bypass (LRYGB) in achieving remission of type 2 diabetes (T2D), particularly silastic ring (SR)-LRYGB. We compared the effectiveness of (LSG) versus SR-LRYGB among patients with T2D and morbid obesity.
Prospective, randomised, parallel, 2-arm, blinded clinical trial conducted in a single Auckland (New Zealand) centre. Eligible patients aged 20-55 years, T2D of at least 6 months duration and BMI 35-65 kg/m were randomised 1:1 to LSG (n = 58) or SR-LRYGB (n = 56) using random number codes disclosed after anaesthesia induction. Primary outcome was T2D remission defined by different HbA1c thresholds at 1 year. Secondary outcomes included weight loss, quality of life, anxiety and depressive symptoms, post-operative complications and mortality.
Mean ± standard deviation (SD) pre-operative BMI was 42.5 ± 6.2 kg/m, HbA1c 63 ± 16 mmol/mol (30% insulin-treated, 28% had diabetes duration over 10 years). Proportions achieving HbA1c ≤ 38 mmol/mol, < 42 mmol/mol, < 48 mmol/mol and < 53 mmol/mol without diabetes medication at 1 year in SR-LRYGB vs LSG were 38 vs 43% (p = 0.56), 52 vs 49% (p = 0.85), 75 vs 72% (p = 0.83) and 80 vs 77% (p = 0.82), respectively. Mean ± SD % total weight loss at 1 year was greater after SR-LRYGB than LSG: 32.2 ± 7.7 vs 27.1 ± 7.5%, respectively (p < 0.001). Gastrointestinal complications were more frequent after SR-LRYGB (including 3 ulcers, 1 anastomotic leak, 1 abdominal bleeding). Quality of life and depression symptoms improved significantly in both groups.
Despite significantly greater weight loss after SR-LRYGB, there was similar T2D remission and psychosocial improvement after LSG and SR-LRYGB at 1 year.
Prospectively registered at Australia and New Zealand Clinical Trials Register (ACTRN 12611000751976) and retrospectively registered at Clinical Trials (NCT1486680).
在实现2型糖尿病（T2D）缓解方面，比较腹腔镜袖状胃切除术（LSG）与腹腔镜Roux-en-Y胃旁路术（LRYGB），尤其是硅胶环（SR）-LRYGB的随机、盲法试验非常少。我们比较了LSG与SR-LRYGB在T2D和病态肥胖患者中的有效性。
在新西兰奥克兰的一个中心进行前瞻性、随机、平行、双臂、盲法临床试验。符合条件的患者年龄在20 - 55岁，T2D病程至少6个月，体重指数（BMI）为35 - 65kg/m²，使用麻醉诱导后披露的随机数字编码将其1:1随机分为LSG组（n = 58）或SR-LRYGB组（n = 56）。主要结局是1年后根据不同糖化血红蛋白（HbA1c）阈值定义的T2D缓解。次要结局包括体重减轻、生活质量、焦虑和抑郁症状、术后并发症及死亡率。
术前平均体重指数（BMI）为42.5±6.2kg/m²，HbA1c为63±16mmol/mol（30%接受胰岛素治疗，28%糖尿病病程超过10年）。1年后，SR-LRYGB组与LSG组在不使用糖尿病药物情况下达到HbA1c≤38mmol/mol、<42mmol/mol、<48mmol/mol和<53mmol/mol的比例分别为38%对43%（p = 0.56）、52%对49%（p = 0.85）、75%对72%（p = 0.83）和80%对77%（p = 0.82）。1年后SR-LRYGB组的平均总体重减轻百分比（均值±标准差）大于LSG组：分别为32.2±7.7%对27.1±7.5%（p < 0.001）。SR-LRYGB术后胃肠道并发症更常见（包括3例溃疡、1例吻合口漏、1例腹腔出血）。两组的生活质量和抑郁症状均有显著改善。
尽管SR-LRYGB术后体重减轻明显更多，但1年后LSG和SR-LRYGB在T2D缓解和心理社会改善方面相似。
前瞻性注册于澳大利亚和新西兰临床试验注册中心（ACTRN 12611000751976），并追溯注册于临床试验数据库（NCT1486680）。
