Fleshman James, Sargent Daniel J, Green Erin, Anvari Mehran, Stryker Steven J, Beart Robert W, Hellinger Michael, Flanagan Richard, Peters Walter, Nelson Heidi
Department of Surgery, Washington University School of Medicine, MO, and Department of General and Colorectal Surgery, St. Joseph Mercy Hospital, MI, USA.
Ann Surg. 2007 Oct;246(4):655-62; discussion 662-4. doi: 10.1097/SLA.0b013e318155a762.
Oncologic concerns from high wound recurrence rates prompted a multi-institutional randomized trial to test the hypothesis that disease-free and overall survival are equivalent, regardless of whether patients receive laparoscopic-assisted or open colectomy.
Eight hundred seventy-two patients with curable colon cancer were randomly assigned to undergo laparoscopic-assisted or open colectomy at 1 of 48 institutions by 1 of 66 credentialed surgeons. Patients were followed for 8 years, with 5-year data on 90% of patients. The primary end point was time to recurrence, tested using a noninferiority trial design. Secondary endpoints included overall survival and disease-free survival. (Kaplan-Meier)
As of March 1, 2007, 170 patients have recurred and 252 have died. Patients have been followed a median of 7 years (range 5-10 years). Disease-free 5-year survival (Open 68.4%, Laparoscopic 69.2%, P=0.94) and overall 5-year survival (Open 74.6%, Laparoscopic 76.4%, P=0.93) are similar for the 2 groups. Overall recurrence rates were similar for the 2 groups (Open 21.8%, Laparoscopic 19.4%, P=0.25). These recurrences were distributed similarly between the 2 treatment groups. Sites of first recurrence were distributed similarly between the treatment arms (Open: wound 0.5%, liver 5.8%, lung 4.6%, other 8.4%; Laparoscopic: wound 0.9%, liver 5.5%, lung 4.6%, other 6.1%).
Laparoscopic colectomy for curable colon cancer is not inferior to open surgery based on long-term oncologic endpoints from a prospective randomized trial.
高伤口复发率引发的肿瘤学问题促使一项多机构随机试验开展，以检验如下假设：无论患者接受腹腔镜辅助结肠切除术还是开放结肠切除术，无病生存期和总生存期都是相等的。
872例可治愈结肠癌患者由66名具备资质的外科医生之一，在48家机构中的1家随机分配接受腹腔镜辅助或开放结肠切除术。对患者进行了8年的随访，90%的患者有5年的数据。主要终点是复发时间，采用非劣效性试验设计进行检验。次要终点包括总生存期和无病生存期（Kaplan-Meier法）。
截至2007年3月1日，170例患者复发，252例患者死亡。患者的中位随访时间为7年（范围5 - 10年）。两组的5年无病生存率（开放手术组68.4%，腹腔镜手术组69.2%，P = 0.94）和5年总生存率（开放手术组74.6%，腹腔镜手术组76.4%，P = 0.93）相似。两组的总体复发率相似（开放手术组21.8%，腹腔镜手术组19.4%，P = 0.25）。这些复发在两个治疗组中的分布相似。首次复发部位在治疗组之间的分布相似（开放手术组：伤口0.5%，肝脏5.8%，肺4.6%，其他8.4%；腹腔镜手术组：伤口0.9%，肝脏5.5%，肺4.6%，其他6.1%）。
基于一项前瞻性随机试验的长期肿瘤学终点，可治愈结肠癌的腹腔镜结肠切除术并不劣于开放手术。
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