[Minimally invasive surgery in malignant tumors? A concept of quality assurance by phased evaluation exemplifed by colorectal carcinoma resection].
The concept of phased clinical scientific evaluation new surgical procedures in oncology is introduced. The principles of this concept are illustrated with the example of laparoscopic resection of colorectal carcinoma. In Phase I animal studies and anatomical studies on human cadavers it has been shown that the anatomical extent of laparoscopic and conventional colorectal resections is comparable. Uncontrolled clinical trials and registries of laparoscopic operations with a low level of evidence did not detect any severe disadvantages of laparoscopic resection of colorectal carcinoma. Controlled randomised phase III a-studies with a a high level of evidence have proven that laparoscopic colorectal resection has important short-term patient benefits when compared to conventional surgery. Controlled randomised Phase III b-Muticentertrials to compare the long-term results of laparoscopic and conventional resections or colorectal cancer are currently on their way worldwide. These multicenter trials will evaluate with the highest level of evidence wether the results of laparoscopic colorectal cancer resection are as good as those for conventional surgery. Patients scheduled for minimal-invasive resection of colorectal carcinoma should be included in one of these multicenter trials. Only after the phased clinical evaluation of the new procedure has been completed, the risk or benefit of minimal-invasive surgery for colorectal cancer can be assessed.
Schwenk
W
W
Universitätsklinik für Allgemein-, Viszeral-, Gefäss- und Thoraxchirurgie, Medizinische Fakultät, Humboldt-Universität zu Berlin, Charité, Campus Mitte. wolfgangschwenk@charite.de
Haase
O
O
Böhm
B
B
Müller
J M
JM
D015179:Colorectal Neoplasms / Q000601:surgery*; D005858:Germany; D006801:Humans; D019060:Minimally Invasive Surgical Procedures; D015337:Multicenter Studies as Topic; D010043:Outcome and Process Assessment, Health Care; D011785:Quality Assurance, Health Care; D016032:Randomized Controlled Trials as Topic