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新辅助放化疗后男性中低位直肠癌直肠模块化切除术的有效性和安全性:短期结果

The effectiveness and safety of rectal modular dissection for male middle and low rectal cancer after neoadjuvant chemoradiation therapy: the short-term outcome.

作者信息

Chen Weijie, Liu Yuxin, An Yang, Qiu Xiaoyuan, Zhou Jiaolin, Cong Lin, Lin Guole

机构信息

Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Shuaifuyuan 1#, Beijing 100730, P. R. China.

出版信息

J Cancer. 2024 Jan 1;15(5):1225-1233. doi: 10.7150/jca.91776. eCollection 2024.

Abstract

The purpose of this study was to assess the efficacy and safety of rectal modular dissection (RMD) in male patients with middle and low rectal cancer. RMD is a technique used to guide the surgical procedure for rectal mobilization, with the ultimate goal of achieving total mesorectal excision. In order to evaluate the effectiveness of RMD, a single-center, non-inferiority randomized clinical trial was carried out. Eligible patients were randomly assigned into two groups: the RMD group and the traditional rectal mobilization (TRM) group. Demographic characteristics, perioperative data and pathological results of the surgical specimens were collected for analysis. additionally, assessments of urogenital function and defecation function were conducted for all participants. A total of 103 patients (RMD group 53 patients and TRM group 50 patients) were included to analyzed. There were no significant differences in age, body mass index, ASA classification, and tumor characteristics between two groups. The RMD group had significantly lower blood loss ( = 0.00), shorter operative duration ( = 0.00), and shorter hospital stay ( = 0.04) compared to the TRM group. The complete rate of mesorectal excision was higher in the RMD group (98.1%) compared to the TRM group (86.0%, = 0.02). In terms of functional outcomes, the RMD group had better evaluation scores for urethral function (IPSS score, = 0.01), erectile function (IIEF-5 score, = 0.00) and defecation function (LARS score, = 0.00) at the one-year postoperative follow-up. The 1-year disease-free survival rate was similar between the two groups ( = 0.28). These results suggest that RMD is an effective and safe approach for achieving total mesorectal excision while promoting better functional outcomes for patients. The trial was registered in Chinese Clinical Trial Registry (ChiCTR2100052094).

摘要

本研究的目的是评估直肠模块化分离术(RMD)在男性中低位直肠癌患者中的疗效和安全性。RMD是一种用于指导直肠游离手术操作的技术,其最终目标是实现直肠系膜全切除。为了评估RMD的有效性,开展了一项单中心、非劣效性随机临床试验。符合条件的患者被随机分为两组:RMD组和传统直肠游离术(TRM)组。收集手术标本的人口统计学特征、围手术期数据和病理结果进行分析。此外,对所有参与者进行泌尿生殖功能和排便功能评估。共纳入103例患者(RMD组53例,TRM组50例)进行分析。两组在年龄、体重指数、美国麻醉医师协会(ASA)分级和肿瘤特征方面无显著差异。与TRM组相比,RMD组的失血量显著更低(P = 0.00)、手术时间更短(P = 0.00)、住院时间更短(P = 0.04)。RMD组的直肠系膜切除完整率(98.1%)高于TRM组(86.0%,P = 0.02)。在功能结局方面,术后1年随访时,RMD组在尿道功能(国际前列腺症状评分,P = 0.01)、勃起功能(国际勃起功能指数-5评分,P = 0.00)和排便功能(低位前切除综合征评分,P = 0.00)方面的评估得分更高。两组的1年无病生存率相似(P = 0.28)。这些结果表明,RMD是一种有效且安全的方法,可实现直肠系膜全切除,同时为患者带来更好的功能结局。该试验已在中国临床试验注册中心注册(ChiCTR2100052094)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dbc3/10861816/8ef0a40948ff/jcav15p1225g001.jpg

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