Trial Information

Comparison of Treatment Outcome for Laparoscopic Colectomy Versus Traditional Open Colectomy for the Treatment of Colorectal Cancer: … A Prospective Randomized Clinical Trial

The appropriateness of laparoscopic surgery for the resection of colorectal cancer has been
the focus of controversy. The pros insist that besides the smaller wound size, laparoscopic
colectomy should induce lesser perioperative stress, which was evidenced by the less pain,
quicker flatus passage, early feeding, and more rapid to resume daily activity and work.
Moreover, since the laparoscopic colectomy induces lesser immunosuppression, this may be
potentially positive for the treatment of colorectal cancer patients. However, the cons
insist that first of all, when the summation of 4 or 5 ports, and incisional wound to
retrieve specimen in laparoscopic colectomy were considered, the total wound size in
laparoscopic colectomy is basically similar to that of the open colectomy. Secondly, since
the laparoscopic surgeons advocated that the extent of intra-abdominal dissection was the
same between laparoscopic and open colectomy, it seems illogical to speculate that
laparoscopic procedure is less invasive for the colorectal cancer patients than the open
procedure. Moreover, in regard of the short-term improvement of life quality (based on the
evaluation of parameters including less painful, quicker to have flatus passage, feeding, to
resume daily activity, to return to work, etc.), there is no denying that these potential
benefits are at the sacrifice of spending more money, and therefore, it is still unknown if
laparoscopic colectomy is cost-effective. Thirdly and most important of all, laparoscopic
colectomy is a more difficult for most surgeons, and therefore the learning curve is more
difficult to overcome. Moreover, many surgeons concerned if pneumoperitoneum during the
laparoscopic procedure will reinforce the intraperitoneal spread of colorectal cancer. Based
on above-mentioned reasons, many colorectal surgeons hesisted between the lines of safety
and efficacy of laparoscopic colectomy.

However, apparently, the laparoscopic colectomy has been enthusiastically used by many
colorectal surgeons in Taiwan, Japan, Europe, and USA, for around 10 years. Further
clarification of the controversies cited above will be based on the evidence-based medicine,
i.e., the randomized, well-controlled, prospective clinical trials. Actually, a handful of
randomized prospective data regarding the laparoscopic colectomy has been appeared in USA
and Europe. However, we still do not have this kind of data in Taiwan, and therefore this
study is important and mandatory.

In this project, we assumed that a difference in cancer-related survival of less then 15%
between treatments indicates an equivalent efficacy. Assuming a 70% 5-year, cancer-related
survival of stage II and III colorectal cancer patients in the open colectomy group, a
minimum of 100 patients per group was required to showed that both surgical techniques were
equivalent with an α-level of 0.20 and a β error of 0.05. Only patients with stage II and
III disease undergoing curative resection will be enrolled onto this study. The patients
will be randomly allocated to either treatment group by block randomization method.
Postoperatively, the patients will be prospectively evaluated regarding the following
parameters including operative stress, such as erythrocyte sedimentation rate, serum
interleukin-6, WBC counts and classification, CD-4 to CD-8 ratio, postoperative life
quality, such as wound size, degree of pain, time to have flatus passage and feeding, time
to resume daily activity and work, and the oncological outcomes, such as recurrence patterns
of tumor, and 5-year patient survival. The evaluation of above-mentioned parameters will be
single-blindly done by our research assistant, who has no idea of both surgical techniques.
We hope this study will promote the level of surgical research in Taiwan.