Despite many important medical advances, surgery remains the primary treatment modality for the majority of the 109,000 individuals who are newly diagnosed with colon cancer each year. Surgery not only provides extirpation of the primary tumor which relieves symptoms and prevents complications, but in addition provides important staging information. Although oncologic results from open colectomy are well-established, these traditional resective and staging techniques are challenged by the introduction of minimal access surgery. Laparoscopic cholecystectomy, an example of minimal access resective surgery has rapidly become the preferred surgical approach to cholelithiasis, due to significant reductions in recovery time, disabilities, and costs. It has been proposed that minimal access surgery of the colon may offer similar advantages. Minimally invasive resections of the colon can be performed using laparoscopic techniques to ligate vasculature, mobilize and exteriorize bowel, and extracorporeal techniques to resect and anastomose bowel. Collective preliminary data from a consortium of experienced laparoscopic surgeons supports that laparoscopic-assisted colectomy is safe, feasible, and reduces recovery times, disabilities, and costs. To date rigorous quality of life and cost analyses have not been performed and further concern has been raised regarding the adequacy of this technique for staging and treatment of colon cancer, a common indication for colectomy. A prospective randomized trial accruing 1,200 patients over three years is proposed to address three SPECIFIC AIMS, The PRIMARY AIM of the study is to test the hypothesis that disease-free survival and overall survival are equivalent regardless of whether patients receive laparoscopic assisted or open colectomy. If a significant adverse affect on cancer outcome is detected, then no further analyses will be recommended. If, however, laparoscopic-assisted colectomy does not adversely affect disease-free or overall survival then further aims will be tested. The SECONDARY AIM of the study is to determine the safety of laparoscopic-assisted colectomy compared to open colectomy, specifically with the respect to operative morbidities and mortality. The TERTIARY AIM of the study is to test the hypothesis that laparoscopic-assisted colectomy is a cost effective alternative to open colectomy and results in superior quality of life. Measurable end points for the quality of life will include symptoms, functional status and utilities, and early and late surgical complications. Measurable end points for cost will include resource utilization for all institutions and actual cost for two institutions. To insure an efficient, successful, high-quality study, an intergroup mechanism will be used to conduct the trial. Although surgical participation will be limited to surgeons who demonstrate expertise in laparoscopic colon surgery, the diverse geographic locations and practice environments of the participating institutions is intended to maximize diversity and the application of the results to the general community.
|Tsikitis, Vassiliki L; Malireddy, Kishore; Green, Erin A et al. (2009) Postoperative surveillance recommendations for early stage colon cancer based on results from the clinical outcomes of surgical therapy trial. J Clin Oncol 27:3671-6|
|Fleshman, James; Sargent, Daniel J; Green, Erin et al. (2007) Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group trial. Ann Surg 246:655-62;discussion 662-4|
|Clinical Outcomes of Surgical Therapy Study Group (2004) A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 350:2050-9|
|Weeks, Jane C; Nelson, Heidi; Gelber, Shari et al. (2002) Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. JAMA 287:321-8|