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Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01657383
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : August 1, 2017
Information provided by (Responsible Party):
David Iannitti, Atrium Health

Brief Summary:
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.

Condition or disease Intervention/treatment
Cancer of Liver Pancreatic Cancer Biliary Tract Cancer Procedure: HPB Surgery

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgical Outcomes Database for Faculty of Hepatopancreatico Biliary Surgery
Actual Study Start Date : April 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Hepatopancreaticobiliary (HPB) Surgery Patients
Patients undergoing surgical HPB procedures
Procedure: HPB Surgery
Hepatopancreatico Biliary Surgery

Primary Outcome Measures :
  1. Surgical Outcome [ Time Frame: 1 year ]
    Quality of life evaluation after surgical intervention.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hepatopancreatico Biliary surgical patients.

Inclusion Criteria:

  • Patients that are Hepatopancreatico Biliary surgical patients.

Exclusion Criteria:

  • Patients that are not Hepatopancreatico Biliary surgical patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01657383

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United States, North Carolina
Carolinas Health System
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Atrium Health
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Principal Investigator: David A Iannitti, MD Atrium Health
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Responsible Party: David Iannitti, MD, FACS, Atrium Health Identifier: NCT01657383    
Other Study ID Numbers: 04-12-02E
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Biliary Tract Diseases
Liver Diseases