CLASICC
UK MRC CLASICC: Conventional versus Laparoscopic-Assisted Surgery in Colorectal Cancer
N = 794
- Population
- 794 patients with colorectal cancer, colon and rectum together (the abstracts do not separate colon-only counts); 253 and 484 patients actually received open and laparoscopic-assisted treatment.
- Design
- Multicentre randomised controlled trial in 27 UK centres, July 1996 to July 2002, comparing laparoscopic-assisted with open surgery for colorectal cancer; randomisation 2:1 in favour of laparoscopic-assisted surgery. Primary short-term endpoints: positivity rates of circumferential and longitudinal resection margins, proportion of Dukes' C2 tumours, and in-hospital mortality. Analysis by intention to treat. Registered ISRCTN74883561. Long-term outcomes (3-year and 5-year) were reported later.
- Primary endpoint
- Resection margin positivity, Dukes' C2 tumours, In-hospital mortality
- Arms
- Open surgery (control, n = 268): Conventional open surgery
- Laparoscopic-assisted surgery (experimental, n = 526): Laparoscopic-assisted surgery
- People
- Guillou PJ, UK MRC CLASICC Trial Group
Δ Dukes' C2 tumours−1 pointsΔ In-hospital mortality−1 points
Show the numbers
| Endpoint | Analysis | Laparoscopic-assisted surgery | Open surgery | Effect |
|---|---|---|---|---|
| Dukes' C2 tumoursITT (as stated in the abstract); patients with colorectal cancer, colon and rectum together (794) | primaryGuillou 2005 | 6% | 7% | P=0.89Counts as published: 18 patients (7%) open and 34 (6%) laparoscopic; difference -0.3% (95% CI -3.9 to 3.4). Colon and rectal cancer together. |
| In-hospital mortalityITT (as stated in the abstract); patients with colorectal cancer, colon and rectum together (794) | primaryGuillou 2005 | 4% | 5% | P=0.57Counts as published: 13 patients (5%) open and 21 (4%) laparoscopic; difference -0.9% (95% CI -3.9 to 2.2). Colon and rectal cancer together. |
| Endpoint | Analysis | Laparoscopic-assisted surgery | Open surgery | Effect |
|---|---|---|---|---|
| Dukes' C2 tumoursITT (as stated in the abstract); patients with colorectal cancer, colon and rectum together (794) | primaryGuillou 2005 | 6% | 7% | P=0.89Counts as published: 18 patients (7%) open and 34 (6%) laparoscopic; difference -0.3% (95% CI -3.9 to 3.4). Colon and rectal cancer together. |
| In-hospital mortalityITT (as stated in the abstract); patients with colorectal cancer, colon and rectum together (794) | primaryGuillou 2005 | 4% | 5% | P=0.57Counts as published: 13 patients (5%) open and 21 (4%) laparoscopic; difference -0.9% (95% CI -3.9 to 2.2). Colon and rectal cancer together. |