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Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy

Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy in a High Volume Hospital.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01059097
Enrollment
610
Registered
2010-01-29
Start date
2001-08-31
Completion date
2010-01-31
Last updated
2010-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer, Pancreatic Surgery

Brief 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.

Detailed 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.

Interventions

PROCEDUREPancreaticoduodenectomy

Sponsors

Università Vita-Salute San Raffaele
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009

Exclusion criteria

* Other type of surgery

Design outcomes

Primary

MeasureTime frame
Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge30 days after discharge

Secondary

MeasureTime frame
Postoperative morbidity rate measuring the following complications: pancreatic fistula, biliary fistula, delayed gastric emptying, infectious complications, bleeding, cardiovascular complications, respiratory complications.30 days post-discharge
Postoperative hospital stay. Measuring the length of hospital stay.At day of discharge

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026