From VU University Medical Center (H.J.B., C.L.D., G.A.A., M.A.C., M.H.G.M.P., E.S.M.L.-K.) and Amsterdam Medical Center (W.A.B.) - both in Amsterdam; Hospital Clinic I Provincial de Barcelona, Barcelona (A.M.L.); the Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital-Östra, Gothenburg, Sweden (J.A., E.A., E.H.); Herlev Hospital, Department of Surgery, University of Copenhagen, Copenhagen (J.R.); and Caritas Krankenhaus St. Josef, Regensburg, Germany (A.F.).
N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882.
Laparoscopic resection of colorectal cancer is widely used. However, robust evidence to conclude that laparoscopic surgery and open surgery have similar outcomes in rectal cancer is lacking. A trial was designed to compare 3-year rates of cancer recurrence in the pelvic or perineal area (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer.
In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without distant metastases to undergo either laparoscopic or open surgery in a 2:1 ratio. The primary end point was locoregional recurrence 3 years after the index surgery. Secondary end points included disease-free and overall survival.
A total of 1044 patients were included (699 in the laparoscopic-surgery group and 345 in the open-surgery group). At 3 years, the locoregional recurrence rate was 5.0% in the two groups (difference, 0 percentage points; 90% confidence interval [CI], -2.6 to 2.6). Disease-free survival rates were 74.8% in the laparoscopic-surgery group and 70.8% in the open-surgery group (difference, 4.0 percentage points; 95% CI, -1.9 to 9.9). Overall survival rates were 86.7% in the laparoscopic-surgery group and 83.6% in the open-surgery group (difference, 3.1 percentage points; 95% CI, -1.6 to 7.8).
Laparoscopic surgery in patients with rectal cancer was associated with rates of locoregional recurrence and disease-free and overall survival similar to those for open surgery. (Funded by Ethicon Endo-Surgery Europe and others; COLOR II ClinicalTrials.gov number, NCT00297791.).
腹腔镜结直肠癌切除术被广泛应用。然而，缺乏强有力的证据表明腹腔镜手术和开腹手术在直肠癌患者中具有相似的结果。本试验旨在比较腹腔镜和开腹直肠切除术 3 年盆腔或会阴部（局部复发）癌症复发率和生存情况。
在这项在 30 家医院进行的国际试验中，我们将距离肛门 15cm 以内、未侵犯邻近组织且无远处转移的单一直肠腺癌患者按 2:1 的比例随机分配接受腹腔镜或开腹手术。主要终点为指数手术后 3 年的局部区域复发率。次要终点包括无病生存和总生存。
共纳入 1044 例患者（腹腔镜手术组 699 例，开腹手术组 345 例）。3 年后，两组的局部区域复发率分别为 5.0%（差异为 0 个百分点；90%置信区间为 -2.6 至 2.6）。腹腔镜手术组的无病生存率为 74.8%，开腹手术组为 70.8%（差异为 4.0 个百分点；95%置信区间为 -1.9 至 9.9）。腹腔镜手术组的总生存率为 86.7%，开腹手术组为 83.6%（差异为 3.1 个百分点；95%置信区间为 -1.6 至 7.8）。
腹腔镜手术治疗直肠癌的局部复发率以及无病生存和总生存率与开腹手术相似。（由 Ethicon Endo-Surgery Europe 等资助；COLOR II ClinicalTrials.gov 编号，NCT00297791。）
