H Nelson1. 1. Department of Surgery, Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, MN, USA. nelson.heidi@mayo.edu
Abstract
OBJECTIVES: A prospective randomized trial was designed to test the hypothesis that disease-free survival and overall survival are equivalent regardless of whether patients receive laparoscopic assisted colectomy (LAC) or open colectomy. Secondary and tertiary aims will test the safety of LAC and the impact of LAC on quality of life and costs, respectively. METHODS:1200 patients will be accrued and randomly assigned to LAC or open colectomy. Consenting adults with primary colon cancer without previous or concurrent malignancies and with tumors considered resectable for cure are eligible for enrollment. Patients will be followed postoperatively for evidence of recurrence and for survival and perioperatively for morbidity, mortality, quality of life, and cost end points. RESULTS: Over 800 patients have been enrolled to date. Early trial results are available for 408 patients, 203 open and 205 LAC. As anticipated, patients are evenly distributed within the two treatment arms according to age, gender, and anesthesia risk (ASA classification). In the open arm, the mean age is 69 with 52 percent females, 87 percent ASA I/II and 13 percent ASA III. In the laparoscopic arm, the mean age is 67, with 48 percent females, 87 percent ASA I/II, and 13 percent ASA III. A total of 160 right and 117 sigmoid colectomies have been performed. Extent of resection data is also available and all parameters tested show no difference between the LAC and open cases: for the laparoscopic vs open colectomy, total bowel length 26 cm vs 27 cm; proximal margins 12 cm vs 11 cm; distal margins 10 cm vs 12 cm; mesenteric length 9 cm vs 8 cm. Similarly, the number of nodes resected for laparoscopic colectomy is essentially the same (mean 12 lymph nodes) to that for open surgery (mean 13 nodes). CONCLUSIONS: Although this study is ongoing; preliminary results suggest that open and LAC provide for the same extent of resection. The quality of life portion of the study is now complete and data will soon be available.
RCT Entities:
OBJECTIVES: A prospective randomized trial was designed to test the hypothesis that disease-free survival and overall survival are equivalent regardless of whether patients receive laparoscopic assisted colectomy (LAC) or open colectomy. Secondary and tertiary aims will test the safety of LAC and the impact of LAC on quality of life and costs, respectively. METHODS: 1200 patients will be accrued and randomly assigned to LAC or open colectomy. Consenting adults with primary colon cancer without previous or concurrent malignancies and with tumors considered resectable for cure are eligible for enrollment. Patients will be followed postoperatively for evidence of recurrence and for survival and perioperatively for morbidity, mortality, quality of life, and cost end points. RESULTS: Over 800 patients have been enrolled to date. Early trial results are available for 408 patients, 203 open and 205 LAC. As anticipated, patients are evenly distributed within the two treatment arms according to age, gender, and anesthesia risk (ASA classification). In the open arm, the mean age is 69 with 52 percent females, 87 percent ASA I/II and 13 percent ASA III. In the laparoscopic arm, the mean age is 67, with 48 percent females, 87 percent ASA I/II, and 13 percent ASA III. A total of 160 right and 117 sigmoid colectomies have been performed. Extent of resection data is also available and all parameters tested show no difference between the LAC and open cases: for the laparoscopic vs open colectomy, total bowel length 26 cm vs 27 cm; proximal margins 12 cm vs 11 cm; distal margins 10 cm vs 12 cm; mesenteric length 9 cm vs 8 cm. Similarly, the number of nodes resected for laparoscopic colectomy is essentially the same (mean 12 lymph nodes) to that for open surgery (mean 13 nodes). CONCLUSIONS: Although this study is ongoing; preliminary results suggest that open and LAC provide for the same extent of resection. The quality of life portion of the study is now complete and data will soon be available.
Authors: Giorgio Ercolani; Gian Luca Grazi; Matteo Ravaioli; Walter Franco Grigioni; Matteo Cescon; Andrea Gardini; Massimo Del Gaudio; Antonino Cavallari Journal: Ann Surg Date: 2004-02 Impact factor: 12.969