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中华腔镜外科杂志(电子版)

中华腔镜外科杂志(电子版) ›› 2024, Vol. 17 ›› Issue (03) : 146 -152. doi: 10.3877/cma.j.issn.1674-6899.2024.03.004

论著

新辅助治疗后男性中低位直肠癌保肛手术中模块化解剖的应用
陈伟杰1, 张潇1, 刘雨馨1, 邱小原1, 张宁1, 张冠南1, 陆君阳1, 周皎琳1, 林国乐1,†()   
  1. 1. 100730　北京，中国医学科学院北京协和医院基本外科
  • 收稿日期:2024-05-21 出版日期:2024-06-30
  • 通信作者: 林国乐
  • 基金资助:
    中国医学科学院医学与健康科技创新工程项目2021年临床与转化医学研究专项CAMS Innovation Fund for Medical Sciences （CIFMS）(2021-I2M-C&T-B-019); 北京协和医院中央高水平医院临床科研专项(2022-PUMCH-C-005)

Rectum modular dissection applied to radical anus-preserving surgery in men with low rectal cancer after neoadjuvant therapy

Weijie Chen1, Xiao Zhang1, Yuxin Liu1, Xiaoyuan Qiu1, Ning Zhang1, Guannan Zhang1, Junyang Lu1, Jiaolin Zhou1, Guole Lin1,†()   

  1. 1. Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China
  • Received:2024-05-21 Published:2024-06-30
  • Corresponding author: Guole Lin
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陈伟杰, 张潇, 刘雨馨, 邱小原, 张宁, 张冠南, 陆君阳, 周皎琳, 林国乐. 新辅助治疗后男性中低位直肠癌保肛手术中模块化解剖的应用[J]. 中华腔镜外科杂志(电子版), 2024, 17(03): 146-152.

Weijie Chen, Xiao Zhang, Yuxin Liu, Xiaoyuan Qiu, Ning Zhang, Guannan Zhang, Junyang Lu, Jiaolin Zhou, Guole Lin. Rectum modular dissection applied to radical anus-preserving surgery in men with low rectal cancer after neoadjuvant therapy[J]. Chinese Journal of Laparoscopic Surgery(Electronic Edition), 2024, 17(03): 146-152.

目的

探讨直肠模块化解剖(rectum modular dissection，RMD)在新辅助治疗后男性中低位直肠癌患者应用的有效性和安全性。

方法

本研究为一项单中心、随机对照临床研究。符合条件的患者被随机分为RMD组和传统直肠解剖组(TRD)。比较入组患者人口统计学特征、肿瘤分期数据、围手术期恢复情况和标本病理结果，并对患者泌尿生殖功能和排便功能进行了评估和比较。本研究已在中国临床试验注册中心(ChiCTR2100052094)注册。

结果

本研究共纳入了2020年1月至2023年1月就诊的176例患者，RMD组81例，TRD组80例。两组在年龄、体质量指数、基础病和肿瘤特征方面没有显著差异。RMD组的失血量(P<0.01)、手术持续时间(P<0.01)和住院时间(P＝ 0.04)均显著少于TRD组。两组患者标本切缘阳性率(P＝0.10)和系膜完整性(P＝0.62)均无显著统计学差异。两组1年无病生存率保持相似(96.3% vs. 93.8%，P＝0.49)。没有患者死亡或发生远处转移。RMD组在术后1年勃起功能评估(IIEF-5评分，P< 0.01)和排便功能评估(LARS评分，P< 0.01)方面较好。

结论

对于中低位直肠癌新辅助治疗后的男性患者，RMD是一种可靠的游离直肠的方法，能够提高手术质量，更标准地实现全直肠系膜切除(TME)，改善肿瘤学预后和功能恢复。

关键词: 中低位直肠癌, 模块化解剖, 新辅助治疗, 直肠全系膜切除
Objective

To validate the efficacy and safety of rectum modular dissection(RMD) in male patients with low and intermediate rectal cancer after neoadjuvant therapy.

Methods

Eligible patients were divided into the RMD group and the traditional rectum dissection (TRD) group. Demographic characteristics, tumor stage data, perioperative recovery and specimen pathology results of the enrolled patients were compared. patients′ genitourinary and bowel functions were also evaluated and compared. The study was registered with the China Clinical Trial Registry (ChiCTR2100052094).

Results

A total of 176 patients in Jan. 2020 to Jan. 2023 were enrolled in the study. There were 81 patients in the RMD group and 80 patients in the TRD group. There were no significant differences between the two groups in terms of age, body mass index, underlying disease, and tumor characteristics. Blood loss (P< 0.01), duration of surgery (P< 0.01), and length of hospital stay (P=0.04) were significantly less in the RMD group than in the TRD group. There was no statistically significant difference in the rate of positive margins of resected specimens (P= 0.10) or the integrity of the mesentery (P= 0.62) between the two groups, whereas the average number of peri-intestinal lymph nodes resected was higher in the RMD group than in the TRD group (P= 0.04). The 1-year disease-free survival rates in both groups remained similar (96.3% vs. 93.8%, P= 0.49). No patients died or developed distant metastases. The RMD group had a better assessment of erectile function (IIEF-5 score, P< 0.01), and assessment of bowel function (LARS score, P< 0.01) at 1 year after surgery.

Conclusion

In male patients after neoadjuvant treatment with lower rectal cancer, RMD is a reliable method to free the rectum that allows for a more standardized TME. It is expected to improve the patients′ oncologic prognosis and functional recovery.

Key words: Middle and low rectal cancer, Rectal modular dissection, Neoadjuvant therapy, Total mesorectal excision
图1 研究流程图
图2 RMD手术操作直肠前间隙及后间隙切开平面示意图
图3 RMD手术过程注：A.进入直肠后间隙，打开直肠固有筋膜和泌尿生殖筋膜之间的"神圣平面"；B、C.从直肠后间隙向两侧延伸分离，过程中注意避免损伤盆丛及分支；D、E.游离直肠前间隙，在腹膜返折上方1 cm处打开筋膜进入邓氏筋膜前间隙，在距离精囊腺底部约0.5 cm进入直肠固有筋膜前方；F.完整切除直肠标本，保证系膜完整
表1 入组患者临床特征及基线数据
  RMD组 TRD组 P值
入组患者数(例) 81 80  
年龄(岁) 59.1±9.0 58.1±10.9 0.51
BMI (kg/m2) 24.4±3.0 24.4±3.2 0.89
基础病及病史[例(%)]     0.76
合并糖尿病 16(19.8) 7(8.8)  
合并冠心病 8(9.9) 5(6.3)  
腹部手术史 9(11.1) 3(3.8)  
肿瘤情况      
肿瘤大小(cm) 3.2±1.6 3.1±1.6 0.66
临床T分期[例(%)]      
T2 13(16.0) 11(13.8)  
T3～4 68(84.0) 69(86.2) 0.68
临床N分期[例(%)]      
N0 22(27.2) 24(30.0)  
N＋ 59(72.8) 56(70.0) 0.69
距肛缘长度(cm) 6.5±2.0 7.2±2.7 0.06
低位直肠癌 22(27.2) 18(22.5)  
中位直肠癌 59(72.8) 62(77.5) 0.49
位于直肠前壁 16(19.8) 14(17.5)  
位于直肠侧壁及后壁 65(80.2) 66(82.5) 0.71
表2 入组患者围手术期情况
  RMD组 TRD组 P值
入组患者数(例) 81 80  
手术时长(min) 129.0±31.3 154.7±50.4 <0.01
出血量(ml) 35.2±27.7 59.4±57.2 <0.01
无预防性造口[例(%)] 22(27.2) 18(22.5) 0.49
并发症[例(%)] 8(9.9) 12(15.0)  
吻合口漏[例(%)] 5(6.2) 7(8.7)  
造口相关并发症[例(%)] 0 1(1.3)  
尿潴留[例(%)] 3(3.7) 3(3.7)  
肠梗阻[例(%)] 0 1(1.3) 0.66
Clavien-Dindo分级      
Ⅰ～Ⅱ[例(%)] 8(9.9) 8(10.0)  
Ⅲ～Ⅳ[例(%)] 0 4(5.0) 0.12
术后住院时长(d)(median，(P25，P75) 7(7，7) 7(7，8) <0.01
表3 入组患者病理结果特征
  RMD组 TRD组 P值
入组患者数(n) 81 80  
切缘阳性[例(%)] 2(2.5) 7(8.8) 0.10
系膜完整[例(%)] 78(96.3) 69(86.3) 0.62
标本完整度分级[例(%)]      
完整 73(90.1) 65(81.3)  
近完整 5(6.2) 10(12.5)  
不完整 3(3.7) 5(6.2) 0.27
切除淋巴结总数(个) 14.3±6.5 12.5±5.0 0.05
肿瘤分化程度[例(%)]      
高分化 15(18.5) 20(25.0)  
中分化 49(60.5) 45(56.2)  
低分化 17(21.0) 15(18.8) 0.61
病理T分期[例(%)]      
ypT1-2 45(55.6) 52(65.0)  
ypT3-4 36(44.4) 28(35.0) 0.22
病理N分期[例(%)]      
ypN0 65(80.2) 67(83.8)  
ypN＋ 16(19.8) 13(16.3) 0.56
表4 入组患者术后功能评估情况
  RMD组 TRD组 P值
入组患者数(例) 81 80  
排尿功能(IPSS评分)      
术前 1.0(0.0，2.0) 0.0(0.0，2.0) 0.16
术后1年 2.0(0.0，3.0) 2.0(0.0，4.0) 0.25
性功能(IIEF-5评分)      
术前 20.0(18.0，21.5) 21.0(19.0，22.0) 0.11
术后1年 20.0(18.0，21.0) 17.0(16.0，18.0) <0.01
排便功能(LARS评分)      
术前 0.0(0.0，0.0) 0.0(0.0，0.0) 0.27
术后1年 12.0(9.0，23.0) 21.5(12.0，26.0) <0.01
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