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Quality management during development and implementation of complete mesocolic excision in colon carcinoma
In a prospective observational study, the implementation of complete mesocolic excision (CME) from 1978 through to 2014 was examined in light of process and outcome quality during ongoing developments in treatment for colon carcinoma. Data from 2019 patients with stage I–III colon carcinoma were analysed by comparing five time periods – 1978–1984 (pre-CME), 1985–1994 (CME development), 1995–2002 (CME implementation), 2003–2009 (CME) and 2010–2014 (CME) – with a special focus on indicators of process and outcome quality. Over the 37-year period, the patients became older, and right-sided carcinoma was more common and more likely to present at stage I, which is associated with a favourable prognosis. Fewer patients had regional lymph node metastases. The proportion of patients with histology-negative lymph nodes (pN0) with at least 12 examined regional lymph nodes increased significantly, to 100%, as did the curative (R0) resection rate, and the application of adjuvant chemotherapy in stage III colon carcinoma increased to 79%. The 5-year rate of locoregional recurrence decreased significantly, from 6.7% to 2.1% (p=0.008). The cancer-related 5-year survival rate increased significantly, from 78.9% to 90.6% (p<0.001). In multivariate analysis, the date of treatment in the series chronology was found to be an independent prognostic factor for locoregional recurrence (p=0.018) and cancer-related survival (p=0.001). In summary, the quality indicators of process and outcome quality improved with CME. Adjuvant chemotherapy at stage III and multidisciplinary approaches in patients with metachronous distant metastases also improved outcomes. Strict quality management is mandatory to accompany changes in treatment.