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A Randomized Trial

Jane C. Weeks, MD; Heidi Nelson, MD; Shari Gelber, MS; Daniel Sargent, PhD; Georgene Schroeder, MS; for the Clinical Outcomes of Surgical Therapy (COST) Study Group

JAMA. 2002;287:321-328.

Context  Laparoscopic-assisted colectomy (LAC) has emerged as the preferred minimally invasive surgical strategy for diseases of the colon. The safety and efficacy of LAC for colon cancer are unknown, and the nature and magnitude of any quality-of-life (QOL) benefit resulting from LAC for colon cancer is also unknown.

Objective  To compare short-term QOL outcomes after LAC vs open colectomy for colon cancer.

Design, Setting, and Participants  Multicenter, randomized controlled trial (Clinical Outcomes of Surgical Therapy [COST]). Between September 1994 and February 1999, 37 of 48 centers provided data for the QOL component of the trial for 449 consecutive patients with clinically resectable colon cancer.

Main Outcome Measures  Scores on the Symptoms Distress Scale (SDS), Quality of Life Index, and a single-item global rating scale at 2 days, 2 weeks, and 2 months postoperative; duration of postoperative in-hospital analgesic use; and length of stay.

Results  Of 449 patients, 428 provided QOL data. In an intention-to-treat analysis comparing SDS pain intensity, SDS summary, QOL Index summary, and global rating scale scores at each time point, the only statistically significant difference observed between groups was the global rating scale score for 2 weeks postsurgery. The mean (median) global rating scale scores for 2 weeks postsurgery were 76.9 (80) for LAC vs 74.4 (75) for open colectomy (P = .009). While in the hospital, patients assigned to LAC required fewer days of both parenteral analgesics compared with patients assigned to open colectomy (mean [median], 3.2 [3] vs 4.0 [4] days; P<.001) and oral analgesics (mean [median], 1.9 [1] vs 2.2 [2] days; P = .03).

Conclusion  Only minimal short-term QOL benefits were found with LAC for colon cancer compared with standard open colectomy. Until ongoing trials establish that LAC is as effective as open colectomy in preventing recurrence and death from colon cancer, this procedure should not be offered to patients with colon cancer.

Author Affiliations: Department of Adult Oncology, Dana-Farber Cancer Institute, Boston, Mass (Dr Weeks and Ms Gelber); and Departments of Surgery (Dr Nelson) and Biostatistics (Dr Sargent and Ms Schroeder), Mayo Clinic, Rochester, Minn. Drs Weeks and Nelson contributed equally to this article as co-chairs of the Writing Committee.

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