Australasian Multicentered Prospective Randomised Clinical Study Comparing Laparoscopic and Conventional Open Surgical Treatments of Colon Cancer in Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 38
- 主要终点
- Disease-free interval
研究概览
简要总结
The purpose of this study is to compare the short and long term outcomes of people who have colon cancers removed either by laparotomy (a large cut in the abdominal wall) or by a laparoscopic assisted approach (keyhole surgery). This study involves 37 credentialled surgeons in 20 approved hospitals across Australasia and during the recruitment period (Jan 1998 to March 2005) 601 patients were recruited into the ALCCaS Trial.
详细描述
AIMS
The primary aim of the study is to test the hypothesis that tumour related disease free interval and overall survival are equivalent regardless whether patients receive laparoscopic colon resection (LCR) or open colon resection (OCR) at three and five years post operatively. The secondary aims of the study are to determine the safety of LCR compared to OCR and 30 day mortality and compare post operative pain, paralytic ileus, early and late morbidities (including wound site recurrence), recovery, transfusion requirements, cost and quality of life scores.
BACKGROUND
The ALCCaS Trial is an Australasian, multicentred, prospective, randomised clinical study comparing laparoscopic and conventional open surgical treatments of colon cancer in adults. This trial has been recruiting patients since 1998.
Patients are randomised to receive either laparoscopic or conventional open resection for colon cancer. A Randomisation Centre was established to provide a 24-hour randomisation service and this centre is situated in Christchurch, New Zealand. The Health Research Council of New Zealand Data Safety Committee, chaired by Professor Tom Fleming, access the ALCCaS Trial annually to ensure that it meets strict ethical and research related criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of a single adenocarcinoma of the ascending, descending, or sigmoid colon
- •18 years of age or older
- •Able to give informed consent
- •Must be able to participate in follow-up examinations
- •Must not have prohibitive scars or adhesions from previous abdominal surgery
排除标准
- •Advanced local disease, defined as >8cm in diameter or extensive infiltration
- •Any previous or current malignant tumour with the previous 5 years (except superficial squamous or basal cell skin carcinoma or in situ cervical cancer)
- •Associated gastrointestinal disease
- •Dukes D disease
- •Emergency presentation
- •Massive bleeding
- •Morbid obesity
- •Pregnancy
- •Rectal cancer
- •Transverse colon cancer
结局指标
主要结局
Disease-free interval
Three-year survival
Five-year survival
次要结局
- 30-day mortality
- Postoperative pain
- Paralytic ileus
- Early morbidity
- Late morbidity
- Recovery
- Transfusion requirement
- Cost effectiveness
- Quality of Life outcomes