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Oncologic results of laparoscopic versus conventional open surgery for stage II or III left-sided colon cancers: a randomized controlled trial.

机译:腹腔镜与常规开放手术治疗II期或III期左侧结肠癌的肿瘤学结果:一项随机对照试验。

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INTRODUCTION: Minimal invasive surgical approach can achieve quick functional recovery. However, the oncologic outcome for cancer is still a concern. This study aims to compare the oncologic outcome between laparoscopic and open methods in the curative resection of Stage II or III left-sided colon cancers. METHODS: In consideration of statistical power up to 90%, 286 eligible patients with curable left-sided colon cancer (Tumor-Node-Metastasis Stage II and Stage III disease) requiring the takedown of colonic splenic flexure to facilitate a curative left hemicolectomy were recruited randomly and equally allocated to the laparoscopic and open group. The primary endpoint was time-to-recurrence of tumor. Data was analyzed according to intention-to-treat principle. RESULTS: Postrandomization exclusion occurred because of metastatic disease detected intraoperatively occurred in 13 patients and because of patient withdrawal from trial in 4. Therefore, 135 and 134 patients actually comprised the laparoscopic and open group, respectively. The median follow-up of patient was 40 months (range: 18-72 months). The oncologic results were similar (P = 0.362, one-sided log-rank test) in laparoscopic and open group of patients, with the estimated cumulative recurrence rate of 13.2% (9/68) versus 17.2% (11/64) in Stage II disease and 20.9% (14/67) versus 25.7% (18/70) in Stage III disease, respectively. The recurrence patterns were similar between the two groups. Both open and laparoscopic groups were comparable in the number of dissected lymph node (15.6 +/- 3.0 vs. 16.0 +/- 6.0, P = 0.489), various demographic and clinicopathologic parameters. CONCLUSIONS: The estimated cumulative recurrence rate for the surgery of Stage II or III left-sided colon cancers was the same between laparoscopic and open methods.
机译:简介:微创手术方法可实现快速功能恢复。然而,癌症的肿瘤学结果仍然是一个问题。本研究旨在比较腹腔镜和开放式方法在II期或III期左侧结肠癌的根治性切除中的肿瘤学结果。方法:考虑到高达90%的统计学功效,招募了286名合格的可治愈的左侧结肠癌患者(II期和III期肿瘤节点转移),需要切除结肠脾曲张以利于根治性左半结肠切除术随机且均等地分配给腹腔镜和开腹组。主要终点是肿瘤的复发时间。根据意向性治疗原则分析数据。结果:随机后排除的发生是由于13例患者在术中检测到转移性疾病,以及4例患者退出试验。因此,分别有135例和134例患者分别属于腹腔镜和开放组。患者的中位随访时间为40个月(范围:18-72个月)。腹腔镜和开放组患者的肿瘤学结果相似(P = 0.362,单侧对数秩检验),分期的估计复发率分别为13.2%(9/68)和17.2%(11/64)。 II期疾病占20.9%(14/67),III期疾病占25.7%(18/70)。两组之间的复发模式相似。开放组和腹腔镜组在解剖的淋巴结数目(15.6 +/- 3.0 vs. 16.0 +/- 6.0,P = 0.489),各种人口统计学和临床​​病理学参数上均相当。结论:腹腔镜和开放式手术在Ⅱ期或Ⅲ期左侧结肠癌手术中的估计累积复发率相同。

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