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ALCCaS 试验:腹腔镜与开腹结肠癌根治术治疗结肠癌后生活质量的随机对照试验。

The ALCCaS Trial: A Randomized Controlled Trial Comparing Quality of Life Following Laparoscopic Versus Open Colectomy for Colon Cancer.

机构信息

Department of Surgery, University of Otago, Christchurch, New Zealand.

Department of Medicine, University of Otago, Christchurch, New Zealand.

出版信息

Dis Colon Rectum. 2018 Oct;61(10):1156-1162. doi: 10.1097/DCR.0000000000001165.

Abstract

BACKGROUND

This study reports the quality-of-life assessment of the ALCCaS trial. The ALCCaS trial compared laparoscopic and open resection for colon cancer. It reported equivalence of survival at 5 years. Quality of life was measured as a secondary outcome.

OBJECTIVE

This study aimed to report on the quality of life data of the ALCCaS Trial.

DESIGN

This study reports a randomized controlled trial comparing laparoscopic with open colonic resection.

SETTINGS

The study was conducted in Australasia.

PATIENTS

Patients with a single adenocarcinoma of the right, left, or sigmoid colon, presenting for elective treatment, were eligible for randomization.

INTERVENTIONS

Open and laparoscopic colonic resections were performed.

MAIN OUTCOME MEASURES

Patient symptoms and quality of life were measured using the Symptoms Distress Scale, the Quality of Life Index, and the Global Quality of Life Score preoperatively, and at 2 days, 2 weeks, and 2 months postoperatively.

RESULTS

Of the 592 patients enrolled in ALCCaS, 425 completed at least 1 quality-of-life measure at 4 time points (71.8% of cohort). Those who received the laparoscopic intervention had better quality of life postoperatively in terms of the Symptoms Distress Scale (p < 0.01), Quality of Life Index (p < 0.01), and Global Quality of Life (p < 0.01). In intention-to-treat analyses, those assigned to laparoscopic surgery had a better quality of life postoperatively in terms of the Symptoms Distress Scale (p < 0.01) and Quality of Life Index (p < 0.01), whereas Global Quality of Life was not significant (p = 0.056). The subscales better for laparoscopic resection at all 3 postoperative time points were appetite, insomnia, pain, fatigue, bowel, daily living, and health (p < 0.05).

LIMITATIONS

The primary limitation was the different response rates for the 3 quality-of-life measures.

CONCLUSIONS

There was a short-term gain in quality of life maintained at 2 months postsurgery for those who received laparoscopic relative to open colonic resection. See Video Abstract at http://links.lww.com/DCR/A691.

摘要

背景

本研究报告了 ALCCaS 试验的生活质量评估。ALCCaS 试验比较了腹腔镜和开放结直肠癌切除术。它报告了 5 年时生存的等效性。生活质量是作为次要结果进行测量的。

目的

本研究旨在报告 ALCCaS 试验的生活质量数据。

设计

本研究报告了一项比较腹腔镜与开放结肠切除术的随机对照试验。

设置

该研究在澳大拉西亚进行。

患者

患有右、左或乙状结肠癌的单一腺癌、接受择期治疗的患者有资格进行随机分组。

干预措施

进行开放和腹腔镜结肠切除术。

主要观察指标

使用症状困扰量表、生活质量指数和全球生活质量评分在术前以及术后 2 天、2 周和 2 个月时测量患者症状和生活质量。

结果

在 ALCCaS 中纳入的 592 名患者中,425 名至少完成了 4 个时间点的 1 项生活质量测量(队列的 71.8%)。接受腹腔镜干预的患者在术后症状困扰量表(p < 0.01)、生活质量指数(p < 0.01)和全球生活质量(p < 0.01)方面生活质量更好。在意向治疗分析中,与接受腹腔镜手术的患者相比,术后症状困扰量表(p < 0.01)和生活质量指数(p < 0.01)的生活质量更好,而全球生活质量则不显著(p = 0.056)。在所有 3 个术后时间点,腹腔镜切除术后更好的亚量表是食欲、失眠、疼痛、疲劳、肠道、日常生活和健康(p < 0.05)。

局限性

主要限制是 3 项生活质量测量的应答率不同。

结论

与开放结肠切除术相比,接受腹腔镜结肠切除术的患者在术后 2 个月时生活质量短期获益。见视频摘要在 http://links.lww.com/DCR/A691。

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