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Clinical Trial Summary

The independent impact of surgeon volume on outcome of patients undergoing pancreaticoduodenectomy in a high-volume Institution was assessed. A significant reduction of pancreatic fistula rate was found in the high-volume surgeon group in comparison with low-volume surgeon group. However, no difference between groups was found in mortality, major complications, and hospital stay.


Clinical Trial Description

Objectives: To define the independent impact of surgeon volume on outcome after pancreaticoduodenectomy (PD) in a single high-volume institution.

Summary Background Data: The impact of surgeon volume on PD outcome is still controversial. So far, data available are from retrospective multi-institutional reviews, considering in-hospital mortality as the only outcome variable.

Methods: Prospectively collected data on 610 patients who underwent PD from August 2001 to August 2009 were analyzed. Cut-off value to categorize high and low-volume surgeons (HVS and LVS, respectively) was 18 PD/year. Primary endpoint was operative mortality (death within 30-day post-discharge). Secondary endpoints were morbidity, pancreatic fistula (PF) and length of stay. Demographic, clinical, and surgical variables were recorded. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01059097
Study type Interventional
Source Università Vita-Salute San Raffaele
Contact
Status Completed
Phase N/A
Start date August 2001
Completion date January 2010

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