BACKGROUND:Laparoscopic surgery is believed to produce an attenuated metabolic stress response and to have a less dampening effect on the immune response than open surgery. To date, the effect has not been studied in a randomized clinical trial of colorectal cancer. METHODS: The study was a two-armed randomized prospective trial conducted in parallel with the UK Medical Research Council's Conventional versus Laparoscopic-Assisted Surgery in Colorectal Cancer (CLASICC) trial comparing laparoscopically assisted colorectal surgery for left-sided tumours with conventional open surgery. Systemic immunity was assessed by determining the T- and B-cell counts, the CD4 : CD8 ratio, the natural killer cell counts, the immunoglobulin (Ig) G, IgM and IgA levels, and C3 and C4 levels. The white cell phagocytic activity (nitroblue tetrazolium test) was studied before operation and on the third postoperative day. RESULTS: A total of 236 patients were randomized in the immune study between 11 March 1997 and 14 August 1999; 161 had complete preoperative and postoperative assays for the analysis of results. There was no difference in mean response between the two surgical groups for each of the immune parameters studied. The unadjusted difference for the primary endpoint, T-cell count, 3 days after operation was - 1.6 per cent (95 per cent confidence interval - 5.0 to 1.8 per cent). CONCLUSION: There is no difference in the systemic immune response in patients having laparoscopically assisted colectomy compared with those undergoing conventional open surgery for colorectal cancer.
RCT Entities:
BACKGROUND: Laparoscopic surgery is believed to produce an attenuated metabolic stress response and to have a less dampening effect on the immune response than open surgery. To date, the effect has not been studied in a randomized clinical trial of colorectal cancer. METHODS: The study was a two-armed randomized prospective trial conducted in parallel with the UK Medical Research Council's Conventional versus Laparoscopic-Assisted Surgery in Colorectal Cancer (CLASICC) trial comparing laparoscopically assisted colorectal surgery for left-sided tumours with conventional open surgery. Systemic immunity was assessed by determining the T- and B-cell counts, the CD4 : CD8 ratio, the natural killer cell counts, the immunoglobulin (Ig) G, IgM and IgA levels, and C3 and C4 levels. The white cell phagocytic activity (nitroblue tetrazolium test) was studied before operation and on the third postoperative day. RESULTS: A total of 236 patients were randomized in the immune study between 11 March 1997 and 14 August 1999; 161 had complete preoperative and postoperative assays for the analysis of results. There was no difference in mean response between the two surgical groups for each of the immune parameters studied. The unadjusted difference for the primary endpoint, T-cell count, 3 days after operation was - 1.6 per cent (95 per cent confidence interval - 5.0 to 1.8 per cent). CONCLUSION: There is no difference in the systemic immune response in patients having laparoscopically assisted colectomy compared with those undergoing conventional open surgery for colorectal cancer.