BACKGROUND/OBJECTIVES: Central database registrations are widely used tools for assessment of clinical results, but their reliability is subject to debate. The aim of this study is to evaluate the reliability of central database registration for Wilms tumor (WT) nephrectomy-related complications.
DESIGN/METHODS: All Dutch patients undergoing WT nephrectomy according to the International Society of Paediatric Oncology (SIOP) 2001 protocol between 2001 and 2013 were evaluated. Results from the central database were analyzed and compared with data found via individual medical records analysis (gold standard).
RESULTS: A total of 179 patients were included. Fourteen (7.8%) patients with a total of 17 complications were identified in the central database. The medical records revealed that 33 (18.4%) of patients had undergone a total of 41 complications (P < 0.001). Operative complications were similar between the groups (P = 0.157). Eleven short-term complications were noted in the central database versus 27 in the medical records (P = 0.059). Significantly more long-term complications, namely, adhesive small-bowel obstruction, were noted from the medical records compared with the central database (7 vs 1, respectively, P < 0.001). Postoperative chemotherapy was significantly delayed by on average 6 days (P < 0.0001) in patients with complications. No significant effect of complications on event-free survival, overall survival, or the relapse rate was recorded.
CONCLUSION: Central database registrations underestimate the incidence of surgery-related complications after WT nephrectomy and need to be regarded with caution.