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Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy

This study has been completed.
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01059097
First received: January 25, 2010
Last updated: January 28, 2010
Last verified: January 2010
History of Changes

January 25, 2010
January 28, 2010
August 2001
August 2009   (final data collection date for primary outcome measure)
Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01059097 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy
Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy in a High Volume Hospital.

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.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Cancer
  • Pancreatic Surgery
Procedure: Pancreaticoduodenectomy
  • Active Comparator: High volume surgeons
    high volume surgeons performed at least 18 PD/year.
    Intervention: Procedure: Pancreaticoduodenectomy
  • Active Comparator: Low volume surgeons
    low volume surgeons performed less than 18 PD/year.
    Intervention: Procedure: Pancreaticoduodenectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
610
January 2010
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009

Exclusion Criteria:

  • Other type of surgery
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01059097
PANCREAS2010
No
Marco Braga, MD, San Raffaele University
Università Vita-Salute San Raffaele
Not Provided
Principal Investigator: Marco Braga, MD San Raffaele University
Università Vita-Salute San Raffaele
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP