澳大利亚和新西兰关于成人结肠癌腹腔镜手术与开放手术对比的研究:组织与实施
Australian and New Zealand study comparing laparoscopic and open surgeries for colon cancer in adults: organization and conduct.
作者信息
Allardyce Randall A, Bagshaw Philip F, Frampton Christopher M, Frizelle Francis A, Hewett Peter J, Rieger Nicholas A, Smith Shona, Solomon Michael J, Stevenson Andrew R L
机构信息
Department of Surgery, University of Otago, Dunedin, New Zealand.
出版信息
ANZ J Surg. 2008 Oct;78(10):840-7. doi: 10.1111/j.1445-2197.2008.04678.x.
This article describes the initiation and implementation of the multicentre Australia and New Zealand prospective randomized controlled clinical study comparing laparoscopic and conventional open surgical treatments of right-sided and left-sided potentially curable colon cancer (Australasian Laparoscopic Colon Cancer Study). Six hundred and one adult patients were admitted with a clinical diagnosis of a single adenocarcinoma based on a physical examination and colonoscopy, barium enema or computed tomography scan and randomly allocated to either laparoscopic or open surgery. The primary aim of the study is to compare 5-year mortality and tumour recurrence rates between the two groups. Secondary aims include comparisons of safety (intraoperative and early postoperative complications, wound site recurrence, postoperative recovery and 30-day mortality), quality of life, in-hospital costs and short-term mortality and tumour recurrence. The data for 592 patients have been collected. There are currently 3141 person years of follow up. In all 370 patients have been assessed at 5 years. This study shows that large cooperative Australia-New Zealand surgical trials can and should be carried out to address significant clinical issues. When possible, coherence with similar, concurrent international trial protocols ensures broader analyses and applicability of results. It is important to recognize that special attention to sustained funding, surgeon credentialing, clinical protocol standardization, data management, publication policy and the protection of study credibility is required from the outset. The Australasian Laparoscopic Colon Cancer Study will achieve its aims with 5-year assessments of all entered patients in March 2010.
本文描述了一项多中心澳大利亚和新西兰前瞻性随机对照临床研究的启动与实施情况,该研究比较了腹腔镜手术与传统开放手术治疗右侧和左侧潜在可治愈结肠癌的效果(澳大利亚腹腔镜结肠癌研究)。601例成年患者因体格检查、结肠镜检查、钡剂灌肠或计算机断层扫描被临床诊断为单一腺癌,并被随机分配接受腹腔镜手术或开放手术。该研究的主要目的是比较两组的5年死亡率和肿瘤复发率。次要目的包括比较安全性(术中及术后早期并发症、伤口部位复发、术后恢复情况和30天死亡率)、生活质量、住院费用以及短期死亡率和肿瘤复发情况。已收集了592例患者的数据。目前有3141人年的随访时间。共有370例患者接受了5年评估。本研究表明,澳大利亚和新西兰大型合作性外科试验能够且应该开展,以解决重大临床问题。在可能的情况下,与类似的同期国际试验方案保持一致可确保对结果进行更广泛的分析和应用。必须认识到,从一开始就需要特别关注持续资金投入、外科医生资质认证、临床方案标准化、数据管理、出版政策以及研究可信度的保护。澳大利亚腹腔镜结肠癌研究将于2010年3月对所有入组患者进行5年评估,从而实现其目标。