OBJECTIVE: Large national trials may influence surgical practice. In this study the relation between the successful national randomized trial on the management of rectal cancer (the Dutch TME trial) and national ratio of abdomino-perineal resection to low anterior resection and anastomosis was analysed. PATIENTS AND METHODS: In the study period, 1994-99, 15978 patients underwent eitherabdomino-perineal resection (n = 2575) or low anterior resection and anastomosis (n = 13403). The Dutch TME trial started in 1996 and a total of 1530 patients were included by 83 hospitals and 82.1% of these patients were treated from 1997 to 1999. Teaching sessions, tutor assisted surgery and quality control formed an integral and important part of the TME trial. RESULTS: Ratio of abdomino-perineal resection vs. low anterior resection was compared between period I (1994-96) and period II (1997-99). The ratio decreased from 0.19 to 0.13 between period I and II (95% CI, -0.08 to -0.04, P < 0.001). In hospital mortality rate did not change between period I and II (3.5 vs. 3.7, 95% CI, -0.08 to 0.03, P=0.385). CONCLUSION: Significant changes in surgical attitude may accompany successful national randomized trials in which investigated surgical procedures are specified, taught, and controlled. The APR ratio declined by 32% in the Netherlands during and following the Dutch TME trial, without a rise in hospital mortality rate for rectal resections.
RCT Entities:
OBJECTIVE: Large national trials may influence surgical practice. In this study the relation between the successful national randomized trial on the management of rectal cancer (the Dutch TME trial) and national ratio of abdomino-perineal resection to low anterior resection and anastomosis was analysed. PATIENTS AND METHODS: In the study period, 1994-99, 15978 patients underwent either abdomino-perineal resection (n = 2575) or low anterior resection and anastomosis (n = 13403). The Dutch TME trial started in 1996 and a total of 1530 patients were included by 83 hospitals and 82.1% of these patients were treated from 1997 to 1999. Teaching sessions, tutor assisted surgery and quality control formed an integral and important part of the TME trial. RESULTS: Ratio of abdomino-perineal resection vs. low anterior resection was compared between period I (1994-96) and period II (1997-99). The ratio decreased from 0.19 to 0.13 between period I and II (95% CI, -0.08 to -0.04, P < 0.001). In hospital mortality rate did not change between period I and II (3.5 vs. 3.7, 95% CI, -0.08 to 0.03, P=0.385). CONCLUSION: Significant changes in surgical attitude may accompany successful national randomized trials in which investigated surgical procedures are specified, taught, and controlled. The APR ratio declined by 32% in the Netherlands during and following the Dutch TME trial, without a rise in hospital mortality rate for rectal resections.
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