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: August 23, 2013
Last verified: August 2013
  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
Outcomes of Surgical Patients
Procedure: Surgery

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

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Surgical Outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Quality of life evaluation after surgical intervention.


Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgical Patients Procedure: 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David Iannitti, MD, FACS, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01657383     History of Changes
Other Study ID Numbers: 04-12-02E
Study First Received: August 2, 2012
Last Updated: August 23, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 14, 2014