Proposed phase III trial comparing laparoscopic-assisted colectomy versus open colectomy for colon cancer.

Despite many important medical advances, surgery remains the primary treatment modality for most of the 109,000 individuals who are newly diagnosed with colon cancer each year. Surgery not only provides extirpation of the primary tumor that relieves symptoms and prevents complications but also 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, which shortens postoperative recovery and decreases disabilities and cost, has become the preferred surgical approach to cholelithiasis. Many propose that minimal-access surgery of the colon may offer similar advantages. Laparoscopic-assisted segmental resections of the colon can be performed using laparoscopic techniques to ligate vasculature and mobilize and exteriorize bowel and extracorporal techniques to resect and anastomose bowel. Collective preliminary data from a consortium of experienced laparoscopic surgeons support that laparoscopic-assisted colectomy is safe, feasible, and reduces recovery times and disabilities. Since differences between laparoscopic-assisted and open colectomy have not been rigorously tested, and concern has been raised regarding the adequacy of this technique for staging and treating colon cancer, a prospective randomized multi-institutional trial is proposed. The primary aim of such a trial will be to test the hypothesis that disease-free survival and overall survival are equivalent, regardless of whether patients receive laparoscopic-assisted or open colectomy. The secondary aim of the trial will be to determine the safety of of laparoscopic-assisted colectomy compared with open colectomy.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes