Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 2, 2012
August 23, 2013
April 2012
April 2014   (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.
Not Provided
Complete list of historical versions of study NCT01657383 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Not Provided
Non-Probability Sample

Hepatopancreatico Biliary surgical patients.

Outcomes of Surgical Patients
Procedure: Surgery
Hepatopancreatico Biliary Surgery
Surgical Patients
Intervention: Procedure: Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
300
Not Provided
April 2014   (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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01657383
04-12-02E
Yes
David Iannitti, Carolinas Healthcare System
Carolinas Healthcare System
Not Provided
Principal Investigator: David A Iannitti, MD Carolinas Healthcare System
Carolinas Healthcare System
August 2013

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