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The Long-term Results of a Randomized Clinical Trial of Laparoscopy-assisted Versus Open Surgery for Colon Cancer

Lacy, Antonio M. MD, PhD*; Delgado, Salvadora MD, PhD*; Castells, Antoni MD, PhD; Prins, Hubert A. MD, PhD*; Arroyo, Vicente MD, PhD; Ibarzabal, Ainitze MD, PhD*; Pique, Josep M. MD, PhD

doi: 10.1097/SLA.0b013e31816a9d65
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Objective: The aim of this study was to compare the long-term outcome of laparoscopy-assisted colectomy (LAC) and open colectomy (OC) for nonmetastatic colon cancer.

Methods: From November 1993 to July 1998 all patients with adenocarcinoma of the colon were assessed for entry in this single center, clinically randomized trial. Adjuvant therapy and postoperative follow-up were similar in both groups. The primary endpoint was cancer-related survival and secondary endpoints were probability of overall survival and probability of being free of recurrence. Data were analyzed according the intention-to-treat principle.

Results: Two hundred and nineteen patients entered the study (111 LAC group and 108 OC group). The median follow-up was 95 months (range, 77–133). There was a tendency of higher cancer-related survival (P = 0.07, NS) and overall survival (P = 0.06, NS) for the LAC group. Probability of cancer-related survival was higher in the LAC group (P = 0.02) when compared with OC. The regression analysis showed that LAC was independently associated with a reduced risk of tumor relapse (hazard ratio 0.47, 95% CI 0.23–0.94), death from a cancer-related cause (0.44, 0.21–0.92) and death from any cause (0.59, 0.35–0.98).

Conclusions: LAC is more effective than OC in the treatment of colon cancer.

This clinical randomized trial compared the long-term results of laparoscopy-assisted colon resection with the open colon resection for nonmetastatic colon cancer. The Kaplan-Meier analysis demonstrated that patients treated by laparoscopy-assisted colectomy have a higher probability of cancer-related survival than those treated by open surgery (P = 0.02).

From the Departments of *Surgery and †Gastroenterology, and Centro de Investigaciones Biomédicas Esther Koplowitz, IMDiM, IDIBAPS, Hospital Clínic, University of Barcelona, Spain.

Supported in part by grants from the Instituto de Salud Carlos III (RC03/02 and RC03/10) and the Ministerio de Educación y Ciencia (SAF2004-07190).

Reprints: Dr. Antonio M. Lacy, Department of Surgery, Hospital Clínic, Villarroel 170, 08036 Barcelona, Spain. E-mail: alacy@clinic.ub.es.

© 2008 Lippincott Williams & Wilkins, Inc.