Effect of Surgeon Volume on Outcome of Pancreaticoduodenectomy
1 other identifier
interventional
610
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pancreatic-cancer
Started Aug 2001
Longer than P75 for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 25, 2010
CompletedFirst Posted
Study publicly available on registry
January 29, 2010
CompletedJanuary 29, 2010
January 1, 2010
8 years
January 25, 2010
January 28, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative mortality after pancreaticoduodenectomy within 30 days of discharge
30 days after discharge
Secondary Outcomes (2)
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
Study Arms (2)
High volume surgeons
ACTIVE COMPARATORhigh volume surgeons performed at least 18 PD/year.
Low volume surgeons
ACTIVE COMPARATORlow volume surgeons performed less than 18 PD/year.
Interventions
Eligibility Criteria
You may qualify if:
- Patients who underwent pancreaticoduodenectomy between August 2001 and August 2009
You may not qualify if:
- Other type of surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Raffaele Scientific Institute
Milan, MI, 20132, Italy
Related Publications (2)
Balzano G, Zerbi A, Braga M, Rocchetti S, Beneduce AA, Di Carlo V. Fast-track recovery programme after pancreatico- duodenectomy reduces delayed gastric emptying. Br J Surg. 2008 Nov;95(11):1387-93. doi: 10.1002/bjs.6324.
PMID: 18844251BACKGROUNDBalzano G, Zerbi A, Capretti G, Rocchetti S, Capitanio V, Di Carlo V. Effect of hospital volume on outcome of pancreaticoduodenectomy in Italy. Br J Surg. 2008 Mar;95(3):357-62. doi: 10.1002/bjs.5982.
PMID: 17933001BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Braga, MD
San Raffaele University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 25, 2010
First Posted
January 29, 2010
Study Start
August 1, 2001
Primary Completion
August 1, 2009
Study Completion
January 1, 2010
Last Updated
January 29, 2010
Record last verified: 2010-01