Objective: To investigate the safety and learning curve of Da Vinci robotic single-anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S) in the treatment of obesity patients. Methods: A descriptive case series study was performed. Clinical data of obesity patients who were treated with Da Vinci robotic SADI-S in China-Japan Union Hospital of Jilin University from March 2020 to May 2021 were analyzed retrospectively. Case inclusion criteria: (1) uncomplicated obese patients with body mass index (BMI)≥37.5 kg/m(2); (2) patients with BMI of 28 to <37.5 kg/m(2) complicated with type 2 diabetes or two metabolic syndrome components, or obesity comorbidities; (3) patients undergoing SADI-S by Da Vinci robotic surgery system. Those who received other bariatric procedures other than SADI-S or underwent Da Vince robotic SADI-S as revisional operation were excluded. A total of 77 patients were enrolled in the study, including 31 males and 46 females, with median age of 33 (18-59) years, preoperative body weight of (123.0±26.2) kg, BMI of (42.2±7.1) kg/m(2) and waistline of (127.6±16.3) cm. According to the order of operation date, the patients were numbered as 1-77. The textbook outcome (TO) and Clavien-Dindo grading standard were used to analyze the clinical outcome of each patient and to classify surgical complications, respectively. The standard of textbook outcome was as follows: the operative time less than or equal to the 75th percentile of the patient's operation time (210 min); the postoperative hospital stay less than or equal to the 75th percentile of the patient's postoperative hospital stay (7 d); complication grade lower than Clavien grade II; no readmission; no conversion to laparotomy or death. The patient undergoing robotic SADI-S was considered to meet the TO standard when meeting the above 5 criteria. The TO rate was calculated by cumulative sum analysis (CUSUM) method. The curve was drawn by case number as X-axis and CUSUM (TO rate) as Y-axis so as to understand the learning curve of robotic SADI-S. Results: The operative time of 77 robotic SADI-S was (182.9±37.5) minutes, and the length of postoperative hospital stay was 6 (4-55) days. There was no conversion to laparotomy or death. Seven patients suffered from complications (7/77, 9.1%). Four patients had grade II complications (5.2%), including one with duodeno-ileal anastomotic leakage, one with abdominal bleeding, one with peritoneal effusion and one with delayed gastric emptying; two patients were grade IIIb complications (2.6%) and both of them were diagnosed with gastric leakage; one patient was grade IV complication diagnosed with postoperative respiratory failure (1.3%), and all of them were cured successfully. A total of 51 patients met the textbook outcome standard, and the TO rate was positive and was steadily increasing after the number of surgical cases accumulated to the 46th case. Taking the 46th case as the boundary, all the patients were divided into learning stage group (n=46) and mastery stage group (n=31). There were no significant differences between the two groups in terms of gender, age, weight, body mass index, waist circumference, ASA classification, standard liver volume, operative time and morbidity of postoperative complication (all P>0.05). The percent of abdominal drainage tube in learning stage group was higher than that in mastery stage group (54.3% versus 16.1%, P<0.05). The length of postoperative hospital stay in learning stage group was longer than that in mastery stage group [6 (4-22) d versus 6 (5-55) d, P<0.05)]. Conclusion: The Da Vinci robotic SADI-S is safe and feasible with a learning curve of 46 cases.
目的： 探讨达芬奇机器人单吻合口十二指肠回肠旁路联合袖状胃切除术（SADI-S）治疗肥胖患者的安全性及其学习曲线。 方法： 采用描述性病例系列研究方法。回顾性分析2020年3月至2021年5月期间在吉林大学中日联谊医院接受达芬奇机器人SADI-S治疗的肥胖患者的临床资料。单纯肥胖者体质指数≥37.5 kg/m(2)或28 kg/m(2)<体质指数<37.5 kg/m(2)同时合并有2型糖尿病、或两项代谢综合征组分、或肥胖合并症接受SADI-S治疗、且通过达芬奇机器人手术系统完成者纳入研究；排除行SADI-S以外的其他减重术式或以达芬奇机器人SADI-S作为修正手术者。共77例患者纳入本次研究，其中男31例，女46例；中位年龄33（18~59）岁；术前体质量（123.0±26.2） kg，体质指数（42.2±7.1） kg/m(2)，腰围（127.6±16.3） cm。按手术日期先后顺序将入组患者依次编为1~77号，采用教科书效果（TO）来分析每例患者的临床结局，采用Dindo-Clavien分级标准对手术并发症进行分类。TO标准：手术时间小于或等于患者手术时间的第75百分位数（210 min）；术后住院时间小于或等于患者术后住院时间的第75百分位数（7 d）；并发症分级小于Clavien grade Ⅱ级；无再次入院；无中转开腹及死亡。当机器人SADI-S患者同时满足上述5个条件时，则该患者被认为达到了TO标准。采用累积和分析方法（CUSUM）计算患者的TO率，以手术例数为横坐标，TO率为纵坐标绘制散点图，以了解机器人SADI-S的学习曲线。 结果： 77例达芬奇机器人SADI-S患者的手术时间为（182.9±37.5） min，术后中位住院时间为6（4~55） d，无中转开腹及死亡病例。并发症发生率9.1%（7/77），其中4例（5.2%）为Ⅱ级并发症，包括十二指肠回肠吻合口漏、腹腔出血、腹腔积液和胃肠功能恢复延迟各1例；2例（2.6%）为Ⅲb级并发症，均为胃漏；1例（1.3%）Ⅳ级并发症，为术后呼吸功能衰竭，均通过对症处理痊愈出院。有51例患者的临床结局达到了TO标准，TO率在第46例后为正值，且稳步上升。以本组第46例为界，将所有患者分为学习提高组（46例）和熟练掌握组（31例），两组患者在性别、年龄、体质量、体质指数、腰围、美国麻醉医师分级、肝体积及手术时间、术后并发症发生率等方面比较，差异均无统计学意义（均P>0.05）；学习提高组的腹腔引流管留置比为54.3%（25/46），高于熟练掌握组的16.1%（5/31），术后住院时间为6（4~22） d，长于熟练掌握组的6（5~55） d，差异均有统计学意义（均P<0.05）。 结论： 达芬奇机器人SADI-S安全可行；其学习曲线为46例。.
Keywords: Complication; Da Vinci robot; Learning curve; Obesity; Safety; Single anastomosis duodenal-ileal bypass with sleeve gastrectomy.