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Short-term Outcomes of Laparoscopy-Assisted vs Open Surgery for Patients With Low Rectal Cancer The LASRE Randomized Clinical Trial

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机构: [1]Fujian Med Univ, Dept Colorectal Surg, Union Hosp, 29 Xin Quan Rd, Fuzhou 350001, Fujian, Peoples R China [2]Fudan Univ, Zhongshan Hosp, Dept Gen Surg, Shanghai, Peoples R China [3]Peking Univ, Gastrointestinal Canc Ctr, Key Lab Carcinogenesis & Translat Res, Minist Educ,Canc Hosp & Inst, Beijing, Peoples R China [4]Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Gen Surg, Div Colorectal Surg, Beijing, Peoples R China [5]Sichuan Univ, West China Hosp, Dept Gastrointestinal Surg, Chengdu, Peoples R China [6]Sun Yat Sen Univ, Affiliated Hosp 6, Dept Colorectal Surg, Guangzhou, Peoples R China [7]Southern Med Univ, Nanfang Hosp, Dept Gen Surg, Guangzhou, Peoples R China [8]Univ Chinese Acad Sci, Dept Colorectal Surg, Canc Hosp, Hangzhou, Peoples R China [9]Zhejiang Canc Hosp, Hangzhou, Peoples R China [10]China Med Univ, Liaoning Canc Hosp & Inst, Dept Colorectal Surg, Canc Hosp, Shenyang, Peoples R China [11]Gen Hosp PLA, Dept Gen Surg, Beijing, Peoples R China [12]Fujian Prov Canc Hosp, Dept Gastrointestinal Oncol Surg, Fuzhou, Peoples R China [13]Fujian Med Univ, Zhangzhou Affiliated Hosp, Dept Colorectal & Anal Surg, Zhangzhou, Peoples R China [14]Shanghai Jiao Tong Univ, Renji Hosp, Dept Gastrointestinal Surg, Sch Med, Shanghai, Peoples R China [15]Fujian Med Univ, Affiliated Hosp 2, Dept Gastrointestinal Surg, Quanzhou, Peoples R China [16]Xiamen Univ, Affiliated Hosp 1, Dept Gastrointestinal Oncol Surg, Xiamen, Peoples R China [17]Fujian Med Univ, Longyan Affiliated Hosp, Dept Colorectal & Anal Surg, Longyan, Peoples R China [18]Fudan Univ, Dept Colorectal Surg, Canc Ctr, Shanghai, Peoples R China [19]Hubei Prov Canc Hosp, Dept Gastrointestinal Surg, Wuhan, Peoples R China [20]Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Dept Gastrointestinal Surg, Wuhan, Peoples R China [21]Zhejiang Univ, Affiliated Hosp 2, Sch Med, Dept Colorectal Surg & Oncol, Hangzhou, Peoples R China [22]China Med Univ, Shengjing Hosp, Dept Colorectal Oncol Surg, Shenyang, Peoples R China [23]Sun Yat Sen Univ, Dept Colorectal Surg, Canc Ctr, Guangzhou, Peoples R China
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IMPORTANCE The efficacy of laparoscopic vs open surgery for patients with low rectal cancer has not been established. OBJECTIVE To compare the short-term efficacy of laparoscopic surgery vs open surgery for treatment of low rectal cancer. DESIGN, SETTING, AND PARTICIPANTS This multicenter, noninferiority randomized clinical trial was conducted in 22 tertiary hospitals across China. Patients scheduled for curative-intent resection of low rectal cancer were randomized at a 2:1 ratio to undergo laparoscopic or open surgery. Between November 2013 and June 2018, 1070 patients were randomized to laparoscopic (n = 712) or open (n = 358) surgery. The planned follow-up was 5 years. Data analysis was performed from April 2021 to March 2022. INTERVENTIONS Eligible patients were randomized to receive either laparoscopic or open surgery. MAIN OUTCOMES AND MEASURES The short-term outcomes included pathologic outcomes, surgical outcomes, postoperative recovery, and 30-day postoperative complications and mortality. RESULTS A total of 1039 patients (685 in laparoscopic and 354 in open surgery) were included in the modified intention-to-treat analysis (median [range] age, 57 [20-75] years; 620 men [59.7%]; clinical TNM stage II/III disease in 659 patients). The rate of complete mesorectal excision was 85.3% (521 of 685) in the laparoscopic group vs 85.8% (266 of 354) in the open group (difference, -0.5%; 95% CI, -5.1% to 4.5%; P = .78). The rate of negative circumferential and distal resection margins was 98.2% (673 of 685) vs 99.7% (353 of 354) (difference, -1.5%; 95% CI, -2.8% to 0.0%; P = .09) and 99.4% (681 of 685) vs 100% (354 of 354) (difference, -0.6%; 95% CI, -1.5% to 0.5%; P = .36), respectively. The median number of retrieved lymph nodes was 13.0 vs 12.0 (difference, 1.0; 95% CI, 0.1-1.9; P = .39). The laparoscopic group had a higher rate of sphincter preservation (491 of 685 [71.7%] vs 230 of 354 [65.0%]; difference, 6.7%; 95% CI, 0.8%12.8%; P = .03) and shorter duration of hospitalization (8.0 vs 9.0 days; difference, -1.0; 95% CI, -1.7 to -0.3; P = .008). There was no significant difference in postoperative complications rate between the 2 groups (89 of 685 [13.0%] vs 61 of 354 [17.2%]; difference, -4.2%; 95% CI, -9.1% to -0.3%; P = .07). No patient died within 30 days. CONCLUSIONS AND RELEVANCE In this randomized clinical trial of patients with low rectal cancer, laparoscopic surgery performed by experienced surgeons was shown to provide pathologic outcomes comparable to open surgery, with a higher sphincter preservation rate and favorable postoperative recovery.

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大类 | 1 区 医学
小类 | 1 区 肿瘤学
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大类 | 1 区 医学
小类 | 1 区 肿瘤学
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Q1 ONCOLOGY
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Q1 ONCOLOGY

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第一作者机构: [1]Fujian Med Univ, Dept Colorectal Surg, Union Hosp, 29 Xin Quan Rd, Fuzhou 350001, Fujian, Peoples R China
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