AIM: To evaluate long-term outcomes in a large series of patients who randomly received laparoscopic or open colorectal resection. METHODS:From February 2000 to December 2004, six hundred sixty-two patients with colorectal disease were randomly assigned to laparoscopic (LPS, n = 330) or open (n = 332) colorectal resection. All patients were analyzed on an intention-to-treat basis. Long-term follow-up was carried out every 6 mo by office visits. In 526 cancer patients five-year overall anddisease-free survival were evaluated. Median oncologic follow-up was 96 mo. RESULTS: Eight (4.2%) LPS group patients needed conversion to open surgery. Overall long-term morbidity rate was 7.6% (25/330) in the LPS vs 11.1% (37/332) in the open group (P = 0.17). In cancer patients, five-year overall survival was 68.6% in the LPS group and 64.0% in the Open group (P = 0.27). Excluding stage IV patients, five-year local and distant recurrence rates were 32.5% in the LPS group and 36.8% in the Open group (P = 0.36). Further, no difference in recurrence rate was found when patients were stratified according to cancer stage. CONCLUSION:LPS colorectal resection was associated with a slightly lower incidence of long-term complications than open surgery. No difference between groups was found in overall and disease-free survival rates.
RCT Entities:
AIM: To evaluate long-term outcomes in a large series of patients who randomly received laparoscopic or open colorectal resection. METHODS: From February 2000 to December 2004, six hundred sixty-two patients with colorectal disease were randomly assigned to laparoscopic (LPS, n = 330) or open (n = 332) colorectal resection. All patients were analyzed on an intention-to-treat basis. Long-term follow-up was carried out every 6 mo by office visits. In 526 cancerpatients five-year overall and disease-free survival were evaluated. Median oncologic follow-up was 96 mo. RESULTS: Eight (4.2%) LPS group patients needed conversion to open surgery. Overall long-term morbidity rate was 7.6% (25/330) in the LPS vs 11.1% (37/332) in the open group (P = 0.17). In cancerpatients, five-year overall survival was 68.6% in the LPS group and 64.0% in the Open group (P = 0.27). Excluding stage IV patients, five-year local and distant recurrence rates were 32.5% in the LPS group and 36.8% in the Open group (P = 0.36). Further, no difference in recurrence rate was found when patients were stratified according to cancer stage. CONCLUSION: LPS colorectal resection was associated with a slightly lower incidence of long-term complications than open surgery. No difference between groups was found in overall and disease-free survival rates.
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