PURPOSE: To evaluate the impact of laparoscopy compared to open surgery on long-term outcomes in a large series of patients who participated in a randomized controlled trial comparing short-term results of laparoscopic (LPS) versus open colorectal resection. METHODS: This is a retrospective review of a prospective database including 662 patients with colorectal disease (526, 79 % cancer patients) who were randomly assigned to LPS or open colorectal resection and followed every 6 months by office visits. The primary endpoint of the study was long-term morbidity. Secondary outcomes included 10-year overall, cancer-specific, and disease-free survivals. All patients were analyzed on an intention-to-treat basis. RESULTS:Fifty-eight (8.8 %) patients were lost to follow-up. Median follow-up was 131 (IQR 78-153) months in the LPS group and 126 (IQR 52-152) months in the open group (p = 0.121). Overall, long-term morbidity rate was 11.8 % (36/309) in the LPS versus 12.6 % (37/295) in the open group (p = 0.770). Incisional hernia rate was 5.8 % (18/309) in the LPS group versus 8.1 % (24/295) in the open group (p = 0.264). Adhesion-related small-bowel obstruction occurred in five (1.6 %) patients in the LPS versus four (1.4 %) patients in the open group (p = 1.000). In 497 cancer patients, 10-year overall survival was 45.3 % in the LPS group and 40.9 % in the open group (p = 0.160). No difference was found in cancer-specific and disease-free survivals, also when patients were stratified according to cancer stage. CONCLUSION: In this series, LPS colorectal resection was not associated with a lower long-term morbidity rate when compared to open surgery. Overall, cancer-specific and disease-free survivals were similar in cancer patients who were treated with LPS and open surgeries.
RCT Entities:
PURPOSE: To evaluate the impact of laparoscopy compared to open surgery on long-term outcomes in a large series of patients who participated in a randomized controlled trial comparing short-term results of laparoscopic (LPS) versus open colorectal resection. METHODS: This is a retrospective review of a prospective database including 662 patients with colorectal disease (526, 79 % cancerpatients) who were randomly assigned to LPS or open colorectal resection and followed every 6 months by office visits. The primary endpoint of the study was long-term morbidity. Secondary outcomes included 10-year overall, cancer-specific, and disease-free survivals. All patients were analyzed on an intention-to-treat basis. RESULTS: Fifty-eight (8.8 %) patients were lost to follow-up. Median follow-up was 131 (IQR 78-153) months in the LPS group and 126 (IQR 52-152) months in the open group (p = 0.121). Overall, long-term morbidity rate was 11.8 % (36/309) in the LPS versus 12.6 % (37/295) in the open group (p = 0.770). Incisional hernia rate was 5.8 % (18/309) in the LPS group versus 8.1 % (24/295) in the open group (p = 0.264). Adhesion-related small-bowel obstruction occurred in five (1.6 %) patients in the LPS versus four (1.4 %) patients in the open group (p = 1.000). In 497 cancerpatients, 10-year overall survival was 45.3 % in the LPS group and 40.9 % in the open group (p = 0.160). No difference was found in cancer-specific and disease-free survivals, also when patients were stratified according to cancer stage. CONCLUSION: In this series, LPS colorectal resection was not associated with a lower long-term morbidity rate when compared to open surgery. Overall, cancer-specific and disease-free survivals were similar in cancerpatients who were treated with LPS and open surgeries.
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