Colon cancer clinical trial

Laparoscopic removal of the gallbladder is widely employed, yet the extension of laparoscopic approaches to other intra-abdominal surgeries has been slower. An early surgical case series reported concerns about increased cancer recurrence after laparoscopic removal of colon cancer. The Clinical Outcomes of Surgical Therapy Study Group presents long-term follow-up data on a trial of laparoscopic versus open colectomy in patients with colon cancer.

This large multicenter study enrolled adults with adenocarcinoma of the colon, excluding those with severe abdominal adhesions, advanced local or metastatic disease, rectal or transverse colon cancer, inflammatory bowel disease, concurrent cancer, and other severe medical illness. Participants were randomized to laparoscopic or open colectomy. However, 21 percent of patients randomized to a laparoscopic technique had to be converted to open colectomy at the time of surgery.

Complete follow-up data after four years were available for 98 percent of trial participants. Laparoscopic removal of the colon required a longer average operating time (150 minutes) compared with an open approach (95 minutes). Surgical margins and the number of lymph nodes examined were similar between the two techniques. Intraoperative complications occurred in 4 percent of laparoscopic cases and 2 percent of open surgeries, which was not a statistically significant difference.

Over a median follow-up period of 4.4 years, the rate of tumor recurrence was not significantly different between laparoscopic colectomy and open colonic resection (16 versus 18 percent). Overall survival rates and disease-free survival also were similar, and this finding held true for all stages of colon cancer. Tumor recurrence at the site of surgical wounds was uncommon; rates were similar between groups (0.5 in the laparoscopy group compared with 0.2 percent in the open-surgery group). Postoperative recovery was quicker in the laparoscopic group, with a shorter hospital stay (median, five versus six days) and briefer use of parenteral narcotics (median, three versus four days). Short-term postoperative mortality, and rates of readmission and re-operation were similar for both techniques.

The study group concludes that laparoscopic colectomy is at least as effective as a standard open technique with respect to rates of operative complications, tumor recurrence, and overall survival. Laparoscopic removal of the colon requires longer operating times but is associated with quicker postoperative recovery.

The Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med May 13, 2004;350:2050-9.