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OBJECTIVE: To provide a composite endpoint in pancreatic surgery. SUMMARY BACKGROUND DATA: Single endpoints in prospective and randomized studies have become impractical due to their low frequency and the marginal benefit of new interventions. METHODS: Data from prospective studies were used to develop (n=1273) and validate (n=544) a composite endpoint based on postoperative pancreatic fistula, post-pancreatectomy hemorrhage as well as reoperation and reinterventions. All patients had pancreatectomies of different extents. The association of the developed PAncreatic surgery Composite Endpoint (PACE) with prolonged length of hospital stay (LOS) >75th percentile and mortality was assessed. A single-institution database was used for external validation (n = 2666). Sample size calculations were made for single outcomes and the composite endpoint. RESULTS: In the internal validation cohort, the PACE demonstrated an AUC of 78.0%, a sensitivity of 90.4% and a specificity of 67.6% in predicting a prolonged LOS. In the external cohort, the AUC was 76.9%, the sensitivity 73.8% and the specificity 80.1%. The 90-day mortality rate was significantly different for patients with a positive versus a negative PACE both in the development and internal validation cohort (5.1% vs 0.9%; P< 0.001), as well as in the external validation cohort (8.5% vs 1.2%, P< 0.001). The PACE enabled sample size reductions of up to 80.5% compared to single outcomes. CONCLUSION: The PACE performed well in predicting prolonged hospital stays and can be used as a standardized and clinically relevant endpoint for future prospective trials enabling lower sample sizes and therefore improved feasibility compared to single outcome parameters.
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BACKGROUND: With an increase in robot-assisted surgery across all specialties, adequate training and credentialing strategies need to be identified to ensure patients safety. The meta-analysis assesses the transferability of technical surgical skills between laparoscopic surgery, open surgery, and robot-assisted surgery. DESIGN: A systematic search was conducted in Medline, Cochrane Central Register of Controlled Trials, and Web of Science. Outcomes were categorized into time, process, product, and composite outcome measures and pooled separately using Hedges'g (standardized mean difference [SMD]). Subgroup analyses were performed to assess the effect of study design, virtual reality platforms and task difficulty. RESULTS: Out of 14,120 screened studies, 30 were included in the qualitative synthesis and 26 in the quantitative synthesis. Technical surgical skill transfer was demonstrated from laparoscopic to robot-assisted surgery (composite: SMD 0.40, 95%-confidence interval [CI] [0.19; 0.62], time: SMD 0.62, CI [0.33; 0.91]) and vice versa (composite: SMD 0.66, CI [0.33; 0.99], time [basic skills]: SMD 0.36, CI [0.01; 0.72]). No skill transfer was seen from open to robot-assisted surgery with limited available data. CONCLUSION: Technical surgical skills can be transferred from laparoscopic to robot-assisted surgery and vice versa. Robot-assisted and laparoscopic surgical skills training and credentialing should not be regarded separately, but a reasonable combination could shorten overall training times and increase efficiency. Previous experience in open surgery should not be considered as an imperative prerequisite for training in robot-assisted surgery. Recommendations for studies assessing skill transfer are proposed to increase comparability and significance of future studies. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42018104507.