胃袖状切除加非离断空肠旁路术治疗肥胖症的近期疗效分析:一项前瞻性队列研究

Short-term efficacy of laparoscopic sleeve gastrectomy plus uncut jejunojejunostomy(SG-uncut JJB)for treatment of obesity:a prospective study

目的分析胃袖状切除加非离断空肠旁路术(SG-uncut JJB)治疗肥胖症的安全性和近期疗效。方法本研究为前瞻性队列研究(NCT04534504),纳入首都医科大学附属北京朝阳医院普通外科2020年1—12月间收治的肥胖症患者。纳入标准:(1)体质指数>32.5 kg/m^(2),合并或不合并2型糖尿病(T2DM);(2)体质指数为27.5~32.5 kg/m^(2),合并T2DM且内科降糖效果不满意或合并有至少两种代谢性疾病(高血压、脂肪肝、多囊卵巢综合征、痛风和高脂血症);(3)T2DM病程<15年且空腹C肽水平大于正常值下限的50%;(4)腹围男性≥90 cm,女性≥85 cm;(5)年龄16~65岁。排除孕妇、患严重神经或精神疾病、长期服用抗抑郁药和免疫抑制剂、合并严重胃食管反流症状以及修正手术者。入组患者根据医生推荐和患者意愿选择手术方式,分别纳入SG-uncut JJB组或胃袖状切除(SG)组。剔除随访不足1年和随访指标不完整者。主要结局指标是术后1、3、6和12个月的多余体质量减少百分比(%EWL)和总体质量减少百分比(%TWL),次要结局指标是术后并发症和自觉不适反应发生情况,以及代谢性疾病改善情况。随访截至2021年12月1日,随访率100%。结果入组54例患者,剔除7例,最后47例肥胖患者进入研究分析,其中接受SG-uncut JJB手术21例(SG-uncut JJB组),接受SG手术26例(SG组)。SG-uncut JJB组的手术时间和总住院花费显著高于SG组[140(110~180)min比90(70~180)min,Z=-3.642,P=0.001;(5.4±0.6)万元比(4.9±0.7)万元,t=2.590,P=0.013],但术后住院时间、术中出血量及术后并发症率差异无统计学意义(均P>0.05)。SG-uncut JJB组术后恶心、呕吐的发生率低于SG组,差异有统计学意义[9.5%(2/21)比46.2%(12/26),χ^(2)=7.453,P=0.006]。SG-uncut JJB组术后1~12个月,%EWL和%TWL均随时间延长呈逐渐增大的趋势;SG组术后1~6个月,%EWL和%TWL均随时间延长呈现逐渐增大的趋势,而术后12个月时略有回落,差异均有统计学意义(均P=0.001)。在同一时间点,两组%EWL比较的差异无统计学意义,SG-uncut JJB和SG组术后12个月的%EWL分别为(72.4±12.3)%和(63.6±25.7)%;SG-uncut JJB组术后1个月和12个月%TWL均高于SG组[(11.1±2.4)%比(8.2±4.4)%,P=0.011;(29.7±6.9)%比(20.3±7.2)%,P=0.001]。术后12个月时,两组间糖尿病和高血压缓解率、脂肪肝改善率差异无统计学意义(均P>0.05)。结论SG-uncut JJB可以达到与SG相当的减重效果,且术后自觉恶心、呕吐的发生率低,是安全有效的减重代谢手术。

Objective To analyze the short-term efficacy of sleeve gastrectomy plus uncut jejunojejunostomy(SG+uncut JJB)for patients with obesity.Methods This prospective study was conducted in the General Surgery Department of Beijing Chaoyang Hospital from January to December 2020(NCT04534504).The inclusion criteria were patients with a body mass index(BMI)of>32.5 kg/m^(2),type 2 diabetes mellitus(T2DM)or at least two comorbidities with a BMI of 27.5-32.5 kg/m^(2),a waist circumference of>90 cm(male)or>85 cm(female),and those aged between 16 and 65 years.The exclusion criteria included patients who were pregnant,diagnosed with severe neurological or mental illnesses,long-term users of antidepressants and immunosuppressants,and diagnosed with severe gastroesophageal reflux disease or underwent revision surgery.Patients with incomplete follow-up data or insufficient follow-up time were also excluded.Patients were divided into SG-uncut JJB group and SG group according to doctor's recommendation and patients'wills.The primary endpoint was the percentage of excess weight loss(%EWL),and the secondary endpoints were the percentage of total weight loss(%TWL)and the T2DM remission rate.All patients were regularly followed up until the end of December 2020.Results After excluding seven patients who did not meet the inclusion criteria,47 eligible patients were finally identified,with 21 in the SG+uncut JJB group and 26 in the SG group.The operation time(140[110-180]minutes vs.90[70-180]minutes,Z=-3.642,P=0.001)and total cost([54,000±6000]yuan vs.[49,000±7000]yuan,t=2.590,P=0.013)were slightly higher in the SG+uncut JJB group than in the SG group(all P<0.05).However,no significant differences were observed in terms of postoperative hospital stay,operative blood loss,and postoperative complications between the two groups(all P>0.05).The incidence of nausea and vomiting was significantly lower in the SG+uncut JJB group than in the SG group(9.5%[2/21]vs.46.2%[12/26],χ^(2)=7.453,P=0.006).The%EWL and%TWL in the SG+uncut JJB group tended to increase gradually with time.The same trend was also observed in the SG group during the first 6 months of follow-up.The 12-month%EWL and%TWL in the SG group were slightly lower compared with the 6-month%EWL and%TWL(P=0.001).The 12-month%EWL values in the SG+uncut JJB and SG groups were(72.4%±12.3%)and(63.6%±25.7%),respectively.However,no significant differences were observed between the two groups in terms of%EWL.Moreover,the 1-month([11.1%±2.4%]vs.[8.2%±4.4%],P=0.011)and 12-month%TWL([29.7%±6.9%]vs.[20.3%±7.2%],P=0.001)were significantly higher in the SG+uncut JJB group than in the SG group.No significant differences were observed in terms of T2DM and hypertension remission(all P>0.05).Conclusion SG+uncut JJB might achieve a promising weight-loss effect similar to SG with a relatively lower incidence of postoperative nausea and vomiting,and it might be an effective and safe approach for obesity management.