腹腔镜右半结肠癌根治术中闭合系膜裂隙对围手术期影响的全国多中心前瞻性研究

A nationwide multicenter prospective study on the perioperative impact of closure of mesen-teric fissure in laparoscopic right hemicolectomy

  • 摘要:
    目的 探讨腹腔镜右半结肠癌根治术中闭合系膜裂隙对围手术期的影响。
    方法 采用前瞻性随机对照研究方法。选取2022年11月至2023年8月中国医科大学附属第一医院等全国11家医学中心收治的320例行腹腔镜右半结肠癌根治术患者的临床资料,按照区组随机化法将患者分为系膜裂隙非闭合组和系膜裂隙闭合组。观察指标:(1)入组患者分组情况。(2)术中情况。(3)术后情况。偏态分布的计量资料以MQ1,Q3)表示,组间比较采用Mann‑Whitney U检验。计数资料以绝对数或百分比表示,组间比较采用χ²检验或Fisher确切概率法。等级资料比较采用秩和检验。疼痛视觉模拟量表(VAS)评分比较采用广义估计方程分析。
    结果 (1)入组患者分组情况。筛选出符合研究条件的结肠癌患者320例;男156例,女164例;年龄为68(59,73)岁。320例患者随机分配至系膜裂隙非闭合组164例和系膜裂隙闭合组156例。两组患者年龄、体质量指数、美国麻醉医师协会评分、肿瘤最大径、吻合位置、吻合方式、手术入路方式、淋巴结清扫范围、肿瘤分期比较,差异均无统计学意义(P>0.05);性别比较,差异有统计学意义(P<0.05)。(2)术中情况。两组患者术中出血量、手术时间、中转开腹、术中并发症比较,差异均无统计学意义(P>0.05)。系膜裂隙非闭合组3例患者中转开腹;系膜裂隙闭合组1例患者中转开腹。系膜裂隙闭合组2例患者发生术中并发症均为肠系膜血肿。(3)术后情况。两组患者术后总并发症比较,差异无统计学意义(χ²=0.28,P>0.05);其中肠梗阻、腹胀、腹腔积液、胸腔积液、胃瘫、吻合口出血、吻合口漏、手术部位感染比较,差异均无统计学意义(P>0.05)。两组患者再次手术、术后重置胃管比较,差异均无统计学意义(P>0.05);术后首次肛门排气时间、术后首次进食流质食物时间、术后首次肛门排便时间、术后住院时间、总住院费用比较,差异均无统计学意义(Z=-0.01,0.43,1.04,-0.54,-0.36,P>0.05)。系膜裂隙非闭合组1例患者行再次手术。两组患者围手术期均未发生腹内疝和死亡。两组患者术后VAS评分均随时间变化而降低,但VAS评分比较,差异无统计学意义β=-0.20(-0.53,0.13),P>0.05。
    结论 与闭合系膜裂隙比较,腹腔镜右半结肠癌根治术中不闭合系膜裂隙未增加围手术期并发症及术后管理风险。

     

    Abstract:
    Objective To investigate the perioperative impact of closure of mesenteric fissure in laparoscopic right hemicolectomy.
    Methods The prospective randomized controlled trial was conducted. The clinical data of 320 patients who underwent laparoscopic right hemicolectomy in 11 medical centers, including The First Affiliated Hospital of China Medical University et al, from November 2022 to August 2023 were selected. Based on block randomization, patients were alloca-ted into the mesenteric fissure non-closure group and the mesenteric fissure closure group. Observa-tion indicators: (1) grouping of the enrolled patients; (2) intraoperative conditions; (3) postopera-tive conditions. Measurement data with skewed distribution were represented as M(Q1,Q3) and com-parison between groups was conducted using the Mann-Whitney U test. Count data were represen-ted as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test or Fisher's exact probability. Comparison of ordinal data was conducted using the rank sum test. Comparison of visual analog scores was analyzed using generalized estimating equations.
    Results (1) Grouping of the enrolled patients. A total of 320 patients with colon cancer were screened for eligibility, including 156 males and 164 females, aged 68(59,73)years. All the 320 patients were allocated into the mesenteric fissure non-closure group with 164 cases and the mesenteric fissure closure group with 156 cases. There was no significant difference in the age, body mass index, American Society of Anesthesiologist score, maximum tumor diameter, anastomosis location, anastomosis method, surgical approach, range of lymph node dissection, tumor staging between the two groups (P>0.05) and there was a significant difference in the sex between them (P<0.05). (2) Intraoperative conditions. There was no significant difference between the mesenteric fissure closure group and the mesenteric fissure non-closure group in the volume of intraoperative blood loss, operation time, conversion to laparotomy, intraoperative complication (P>0.05). Three patients in the mesenteric fissure non-closure group were converted to laparotomy. One patient in the mesenteric fissure closure group was converted to laparotomy, and 2 cases with intraoperative complication were mesenteric hematoma. (3) Postoperative conditions. There was no significant difference between the mesenteric fissure non-closure group and the mesenteric fissure closure group in the overall postoperative complications (χ2=0.28, P>0.05). There was no significant difference in the occurrence of postoperative intestinal obstruction, abdominal distension, ascites, pleural effusion, gastric paralysis, anastomotic bleeding, anastomotic leakage, or surgical wound infection between the two groups (P>0.05). There was no significant difference between the two groups in the reoperation, postoperative gastric tube replacement. There was no significant differ-ence in time to postoperative first flatus, time to postoperative initial liquid food intake, time to post-operative resumption of bowel movements, duration of postoperative hospital stay, total hospital expenses between the two groups (Z=-0.01, 0.43, 1.04, -0.54, -0.36, P>0.05). One patient in the mesenteric fissure non-closure group received reoperation. No perioperative internal hernia or death occurred in either group. The visual analog score decreased with time in both groups. There was no significant difference in the visual analog score between the mesenteric fissure closure group and the mesenteric fissure non-closure group β=-0.20(-0.53,0.13), P>0.05.
    Conclusion Compared with closure of mesenteric fissure, non-closure of mesenteric fissure during laparoscopic right hemi-colectomy dose not increase perioperative complications or postoperative management risk.

     

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