随机对照试验评估腹腔镜与开腹手术治疗横结肠癌和降结肠癌患者的效果。
Randomized controlled trial to evaluate laparoscopic versus open surgery in transverse and descending colon cancer patients.
机构信息
Department of Gastroenterological Surgery, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.
Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.
出版信息
Int J Colorectal Dis. 2019 Jul;34(7):1211-1220. doi: 10.1007/s00384-019-03305-2. Epub 2019 May 17.
BACKGROUND
The safety and efficacy of laparoscopic surgery for transverse and descending colon cancer remain controversial. This study aimed to evaluate the short- and long-term outcomes of this procedure.
METHODS
We conducted a single-institutional randomized controlled trial. Patients with transverse or descending colon cancer were randomly allocated to receive laparoscopic surgery (LAC) or conventional open surgery (OC). The primary endpoint was the overall complication rate between the two groups. The secondary endpoints were the length of the postoperative hospital stay, the health-related quality of life (HRQOL) score (at 1, 6, and 12 months after surgery), the 5-year relapse-free survival (RFS), and the 5-year overall survival (OS).
RESULTS
Between August 2008 and October 2012, a total of 66 patients were enrolled (33 in the LAC group and 33 in the OC group). The patient characteristics showed no significant differences between the two groups. The complication rates (≥ grade 3) were 6.1% in the LAC group and 12.1% in the OC group (p = 0.392). The length of postoperative stay was not significantly different between the two groups. Regarding the HRQOL, the physical functioning, role physical, bodily pain, social functioning, mental health, and role component summary at 1 month after surgery and the social functioning and mental health at 6 months after surgery were better in the LAC group than in the OC group. The 5-year RFS and OS rates were similar between the LAC and OC groups (RFS 90.5% and 87.3%, respectively, p = 0.752; OS 93.3% and 100.0%, respectively, p = 0.543).
CONCLUSIONS
The short- and long-term outcomes of laparoscopic surgery for transverse and descending colon cancer are almost equal to those of open surgery. Laparoscopic resection is a better choice than open surgery for managing this cancer with regard to the short- and mid-term QOL.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01861691 .
背景
腹腔镜手术治疗横结肠和降结肠癌的安全性和疗效仍存在争议。本研究旨在评估该手术的短期和长期疗效。
方法
我们进行了一项单中心随机对照试验。将患有横结肠或降结肠癌的患者随机分为接受腹腔镜手术（LAC）或传统开腹手术（OC）治疗。主要终点是两组之间的总体并发症发生率。次要终点包括术后住院时间、健康相关生活质量（HRQOL）评分（术后 1、6 和 12 个月）、5 年无复发生存率（RFS）和 5 年总生存率（OS）。
结果
2008 年 8 月至 2012 年 10 月，共纳入 66 例患者（LAC 组 33 例，OC 组 33 例）。两组患者的特征无显著差异。LAC 组并发症发生率（≥3 级）为 6.1%，OC 组为 12.1%（p=0.392）。两组术后住院时间无显著差异。在 HRQOL 方面，LAC 组术后 1 个月时的生理功能、躯体角色功能、躯体疼痛、社会功能、心理健康和角色总分，以及术后 6 个月时的社会功能和心理健康均优于 OC 组。LAC 组和 OC 组的 5 年 RFS 和 OS 率相似（RFS 分别为 90.5%和 87.3%，p=0.752；OS 分别为 93.3%和 100.0%，p=0.543）。
结论
腹腔镜手术治疗横结肠和降结肠癌的短期和长期疗效与开腹手术几乎相同。对于管理这种癌症，腹腔镜切除在短期和中期 QOL 方面优于开腹手术。
试验注册
ClinicalTrials.gov 标识符：NCT01861691。
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