比较腹腔镜与传统开放手术治疗结肠癌的澳大拉西亚随机临床研究的短期结果:ALCCaS试验
Short-term outcomes of the Australasian randomized clinical study comparing laparoscopic and conventional open surgical treatments for colon cancer: the ALCCaS trial.
作者信息
Hewett Peter J, Allardyce Randall A, Bagshaw Philip F, Frampton Christopher M, Frizelle Francis A, Rieger Nicholas A, Smith J Shona, Solomon Michael J, Stephens Jacqueline H, Stevenson Andrew R L
机构信息
Division of Surgery, The Queen Elizabeth Hospital, Woodville South, Australia.
出版信息
Ann Surg. 2008 Nov;248(5):728-38. doi: 10.1097/SLA.0b013e31818b7595.
BACKGROUND
Laparoscopy has revolutionized many abdominal surgical procedures. Laparoscopic colectomy has become increasingly popular. The short- and long-term benefits and satisfactory surgical oncological treatment of colorectal cancer by laparoscopic-assisted resection remain topical. The long-term outcomes of all international randomized controlled trials are still awaited, and short-term outcomes are important in the interim.
METHODS
Between January 1998 and April 2005, a multicenter, prospective, randomized clinical trial in patients with colon cancer was conducted. Six hundred and one eligible patients were recruited by 33 surgeons from 31 Australian and New Zealand centers. Patients were allocated to colectomy by either laparoscopic-assisted surgery (n = 294) or open surgery (n = 298). Patient demographics and secondary end-points, such as operative and postoperative complications, length of hospital stay, and histopathological data, will be presented in this article. Analysis was by intention-to-treat. Survival will be reported only as the study matures.
RESULTS
Histopathological parameters were similar between the two groups, except in regard to distal resection margins. There was no statistically significant difference found in postoperative complications, reoperation rate, or perioperative mortality. Statistically significant differences in quicker return of gastrointestinal function and shorter hospital stay were identified in favor of laparoscopic-assisted resection. A statistically significant increased rate of infective complications was seen in cases converted from laparoscopic-assisted to open procedures but with no difference in reoperation or in-hospital mortality.
CONCLUSIONS
Laparoscopic-assisted colonic resection gives significant improvements in return of gastrointestinal function and length of stay, with an increased operative time and no difference in the postoperative complication rate.
背景
腹腔镜技术给许多腹部外科手术带来了变革。腹腔镜结肠切除术越来越受欢迎。腹腔镜辅助切除治疗结直肠癌的短期和长期益处以及令人满意的肿瘤外科治疗效果仍是热门话题。所有国际随机对照试验的长期结果仍有待观察,在此期间短期结果很重要。
方法
1998年1月至2005年4月,对结肠癌患者进行了一项多中心、前瞻性、随机临床试验。来自澳大利亚和新西兰31个中心的33名外科医生招募了601名符合条件的患者。患者被分配接受腹腔镜辅助手术(n = 294)或开放手术(n = 298)进行结肠切除术。本文将呈现患者人口统计学和次要终点,如手术及术后并发症、住院时间和组织病理学数据。分析采用意向性分析。仅在研究成熟时报告生存率。
结果
两组间组织病理学参数相似,但远端切缘除外。术后并发症、再次手术率或围手术期死亡率无统计学显著差异。在胃肠功能恢复更快和住院时间更短方面发现了有利于腹腔镜辅助切除的统计学显著差异。从腹腔镜辅助手术转为开放手术的病例中,感染性并发症发生率有统计学显著增加,但再次手术率或住院死亡率无差异。
结论
腹腔镜辅助结肠切除术在胃肠功能恢复和住院时间方面有显著改善,手术时间增加,术后并发症发生率无差异。