Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy in a High Volume Hospital.|
- Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]
- Postoperative morbidity rate measuring the following complications: pancreatic fistula, biliary fistula, delayed gastric emptying, infectious complications, bleeding, cardiovascular complications, respiratory complications. [ Time Frame: 30 days post-discharge ] [ Designated as safety issue: No ]
- Postoperative hospital stay. Measuring the length of hospital stay. [ Time Frame: At day of discharge ] [ Designated as safety issue: No ]
|Study Start Date:||August 2001|
|Study Completion Date:||January 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Active Comparator: High volume surgeons
high volume surgeons performed at least 18 PD/year.
Active Comparator: Low volume surgeons
low volume surgeons performed less than 18 PD/year.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059097
|San Raffaele Scientific Institute|
|Milan, MI, Italy, 20132|
|Principal Investigator:||Marco Braga, MD||San Raffaele University|