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Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01657383
First Posted: August 6, 2012
Last Update Posted: August 1, 2017
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.
Information provided by (Responsible Party):
David Iannitti, Carolinas Healthcare System
  Purpose
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 Intervention
Cancer of Liver Pancreatic Cancer Biliary Tract Cancer Procedure: HPB Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgical Outcomes Database for Faculty of Hepatopancreatico Biliary Surgery

Resource links provided by NLM:


Further study details as provided by David Iannitti, Carolinas Healthcare System:

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


Enrollment: 74
Actual Study Start Date: April 2012
Study Completion Date: February 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hepatopancreaticobiliary (HPB) Surgery Patients
Patients undergoing surgical HPB procedures
Procedure: HPB Surgery
Hepatopancreatico Biliary 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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients that are Hepatopancreatico Biliary surgical patients.

Exclusion Criteria:

  • Patients that are not Hepatopancreatico Biliary surgical patients.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01657383


Locations
United States, North Carolina
Carolinas Health System
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: David A Iannitti, MD Carolinas Healthcare System
  More Information

Responsible Party: David Iannitti, MD, FACS, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01657383     History of Changes
Other Study ID Numbers: 04-12-02E
First Submitted: August 2, 2012
First Posted: August 6, 2012
Last Update Posted: August 1, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Pancreatic Neoplasms
Biliary Tract Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Diseases
Liver Diseases