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

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

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。

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.