Minimally invasive surgery for malignant diseases? A concept of quality assurance by evaluation of resections for colorectal cancer

The concept of phased clinical scientific evaluation new surgical procedure s in oncology is introduced. The principles of this concept are illustrated with the example of laparoscopic resection of colorectal carcinoma. In Pha se I animal studies and anatomical studies on human cadavers it has been sh own that the anatomical extent of laparoscopic and conventional colorectal resections is comparable. Uncontrolled clinical trials and registries of la paroscopic operations with a low level of evidence did not detect any sever e disadvantages of laparoscopic resection of colorectal carcinoma. Controll ed randomised phase IIIa-studies with a a high level of evidence have prove n that laparoscopic colorectal resection has important short-term patient b enefits when compared to conventional surgery. Controlled randomised Phase IIIb-Multicentertrials to compare the long-term results of laparoscopic and conventional resections or colorectal cancer are currently on their way wo rldwide. These multicenter trials will evaluate with the highest level of e vidence wether the results of laparoscopic colorectal cancer resection are as good as those for conventional surgery. Patients scheduled for minimal-i nvasive resection of colorectal carcinoma should be included in one of thes e multicenter trials. Only after the phased clinical evaluation of the new procedure has been completed, the risk or benefit of minimal-invasive surge ry for colorectal cancer can be assessed.