国产机器人辅助单孔+1远端胃癌根治术的临床价值

Clinical value of domestic robotic-assisted single‑port plus one radical distal gastrectomy

  • 摘要:
    探讨国产机器人辅助单孔+1远端胃癌根治术的临床价值。
    采用回顾性描述性研究方法。收集2024年8月至2025年8月温州医科大学附属第一医院收治的25例行国产机器人辅助单孔+1远端胃癌根治术患者的临床病理资料;男19例,女6例;年龄为65(29~78)岁。观察指标:(1)手术情况。(2)术后情况。(3)CUSUM学习曲线分析。(4)随访情况。正态分布的计量资料组间比较采用独立样本t检验,偏态分布的计量资料组间比较采用Mann‑Whitney U检验。
    (1)手术情况。25例患者均完成国产机器人辅助单孔+1远端胃癌根治术,无中转开腹或腹腔镜手术患者;机器人装机时间为(32±5)min,置入机器人器械至腹腔关闭时间为(295±60)min。25例患者单孔切口长度为3.1(2.7~3.4)cm,均行远端胃癌根治术联合D2淋巴结清扫,术中淋巴结清扫数目为27(21~64)枚;15例采用Roux‑en‑Y吻合行消化道重建,10例采用Billroth Ⅱ式吻合行消化道重建;术中出血量为20(10~100)mL,均未输血。(2)术后情况。25例患者术后首次肛门排气时间为(2.5±0.7)d,首次排便时间为(4.5±2.1)d,首次进食流质食物时间为(3.4±1.1)d,首次下床行走且持续≥5 min的时间为(3.0±1.3)d;4例发生Clavien‑Dindo≥Ⅱ级术后并发症,其中Ⅱ级并发症3例,Ⅲb级并发症1例,围手术期主要并发症发生率为16%(4/25);术后住院时间为(7.6±1.6)d,住院费用为(53 964±11 543)元。25例患者术后病理学检查结果显示:未分化癌、低分化癌、中高分化癌分别为1、12、12例;肿瘤最大径为2.0(0.3~5.0)cm;TNM分期Ⅰ、Ⅱ、Ⅲ期分别为16、5、4例;患者均未检出远处转移,肿瘤切缘均为阴性。(3)CUSUM学习曲线分析。CUSUM学习曲线结合分段回归模型的分析结果显示:手术时间在第11例达到稳定阶段,术中出血量在第17例达到稳定阶段,术中淋巴结清扫数目在第18例达到稳定阶段,术后住院时间在第16例达到稳定阶段。25例患者学习阶段、稳定阶段的手术时间和术中淋巴结清扫数目比较,差异均有统计学意义(t=3.57,U=23.00,P<0.05);术中出血量、术后住院时间比较,差异均无统计学意义(U=101.50,t=1.38,P>0.05)。(4)随访情况。25例患者均获得随访,随访时间为6(1~12)个月。1例患者因肠梗阻再入院,经手术治疗后好转;24例患者均未诉明显腹痛、腹胀等不适。随访期间,25例患者均无肿瘤局部复发和远处转移,均未出现术后迟发性出血、吻合口瘘、吻合口狭窄相关并发症。
    国产机器人可应用于单孔+1远端胃癌根治术。

     

    Abstract:
    Objective To investigate the clinical value of domestic robotic-assisted single-port plus one radical distal gastrectomy.
    Methods The retrospective and descriptive study was conducted. The clinicopathological data of 25 patients who underwent domestic robotic‑assisted single‑port plus one radical distal gastrectomy at the First Affiliated Hospital of Wenzhou Medical University from August 2024 to August 2025 were collected. There were 19 males and 6 females, aged 65(range, 29-78)years. Observation indicators: (1) surgical conditions; (2) postoperative conditions; (3) CUSUM learning curve analysis; (4) follow‑up. Comparison of measurement data with normal distribution between groups was conducted using the independent sample t test. Comparison of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test.
    Results (1) Surgical conditions. All 25 patients underwent domestic robotic-assisted single-port plus one radical distal gastrectomy successfully, with no conversion to open surgery or laparoscopic surgery. The robotic setup time was (32±5)minutes, time from inserting robotic instruments to closing the abdominal cavity was (295±60)minutes. The single‑port incision length of 25 patients was 3.1(range, 2.7-3.4)cm. All 25 patients underwent radical distal gastrectomy with D2 lymph node dissection, with the number of lymph node dissected as 27(range, 21-64). Of 25 patients, 15 patients underwent Roux‑en‑Y anastomosis, and 10 patients underwent Billroth Ⅱ anastomosis. The volume of intraoperative blood loss of 25 patients was 20(range, 10-100)mL, and no blood transfusion was performed. (2) Postoperative conditions. The time to postoperative first flatus of 25 patients was (2.5±0.7)days, time to postoperative first defecation was (4.5±2.1)days, time to postoperative first liquid diet intake was (3.4±1.1)days, and time to postoperative first ambulation ≥5 minutes was (3.0±1.3)days. Four patients developed postoperative complications of ≥grade Ⅱ Clavien‑Dindo classification , including 3 cases of grade Ⅱ and 1 case of grade Ⅲb. The incidence of major perioperative complications was 16%(4/25). Duration of postoperative hospital stay of 25 patients was (7.6±1.6)days, and the hospitalization cost was (53 964±11 543)yuan. Results of postoperative pathological examination showed 1 case of undifferentiated carcinoma, 12 cases of poorly differentiated carcinoma, 12 cases of moderate‑well differentiated carcinoma, tumor diameter of 25 patients as 2.0(range, 0.3-5.0)cm, 16 cases of TNM stage Ⅰ, 5 cases of TNM stage Ⅱ, 4 cases of TNM stage Ⅲ, none of patient with tumor distant metastasis and all tumor margins as negative. (3) CUSUM learning curve analysis. Results of CUSUM learning curve combined with segmented regression model showed operation time, volume of intraoperative blood loss, the number of intraoperative lymph node dissected and duration of postoperative hospital stay entered the stable stage after the 11th, 17th, 18th and 16th cases, respectively. There were significant differences in operation time and the number of intraoperative lymph node dissected between the learning stage and stable stage (t=3.57, U=23.00, P<0.05), and there was no significant difference in volume of intraoperative blood loss or duration of postoperative hospital stay between the learning stage and stable stage (U=101.50, t=1.38, P>0.05). (4) Follow‑up. All 25 patients were followed up for 6 (range, 1-12)months. During the follow‑up period, one patient was readmitted due to intes-tinal obstruction and improved after surgical treatment, while the remaining 24 patients did not experience significant discomfort such as abdominal pain or bloating. All 25 patients had no local tumor recurrence or distant metastasis, and no postoperative complications such as delayed bleeding, anastomotic leakage, or anastomotic stenosis occurred.
    Conclusion Clinical application of domestic robotic-assisted single‑port plus one radical distal gastrectomy is safe and feasible.

     

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