Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David Iannitti, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01657383
First received: August 2, 2012
Last updated: February 11, 2016
Last verified: February 2016

August 2, 2012
February 11, 2016
April 2012
December 2016   (final data collection date for primary outcome measure)
Surgical Outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Quality of life evaluation after surgical intervention.
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Complete list of historical versions of study NCT01657383 on ClinicalTrials.gov Archive Site
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Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery
Surgical Outcomes Database for Faculty of Hepatopancreatico Biliary Surgery
The collection of data regarding patient outcomes after surgical intervention creates imperative knowledge to include surgeon performance, cost analysis, base for surgical research and publication, which in turn assist surgeons to improve the standard of care utilizing evidence-based practice.

The concept of disease management stems from a logical evolution in the field of outcomes applications by healthcare provides is the concept of disease management. The basic premise of disease management is that there is a more optimal way to manage patients in order to reduce costs and improve health outcomes. The data collected from patient-reported outcomes allows the physician and staff to screen for specific health conditions, monitor patients individually, evaluate outcomes for specific groups, assess quality of care, determine impact of intervention and predict outcomes. Most of the follow-up results from this study will be obtained directly from the patient during follow-up visits, but other information may be obtained from medical records.

Evaluation of the surgical database Application will identify both patient and procedural variables that can predict adverse outcomes.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Hepatopancreatico Biliary surgical patients.
  • Cancer of Liver
  • Pancreatic Cancer
  • Biliary Tract Cancer
Procedure: HPB Surgery
Hepatopancreatico Biliary Surgery
HPB Surgery
Patients undergoing surgical HPB procedures
Intervention: Procedure: HPB Surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
300
January 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients that are Hepatopancreatico Biliary surgical patients.

Exclusion Criteria:

  • Patients that are not Hepatopancreatico Biliary surgical patients.
Both
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01657383
04-12-02E
Yes
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David Iannitti, Carolinas Healthcare System
Carolinas Healthcare System
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Principal Investigator: David A Iannitti, MD Carolinas Healthcare System
Carolinas Healthcare System
February 2016

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