Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
General Surgery Outcomes Database
This study is currently recruiting participants.
Verified by University Hospitals of Cleveland, October 2008
Sponsored by: University Hospitals of Cleveland
Information provided by: University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00622557
  Purpose

A database has been established to track the outcomes of all cases performed in the University Hospitals Department of Surgery in an effort to improve quality of surgical performance and case management.

Specifically, the purpose of the database will be to support resident training, provide opportunities for quality improvement and an ability to accurately track cases.


Condition
Colon Cancer
Diverticulitis
Colorectal Polyps
Crohn's Disease
Ulcerative Colitis
Rectal Cancer

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Cancer Crohn's Disease Diverticulosis and Diverticulitis Ulcerative Colitis
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: General Surgery Outcomes Database

Further study details as provided by University Hospitals of Cleveland:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 1000
Study Start Date: May 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgical

Detailed Description:

Since the Institute of Medicine report, titled "To Err is Human", there has been an increasing trend to evaluate outcomes in healthcare. While optimal outcomes in delivery of healthcare are something that hospitals and their medical, nursing and administrative staff have always tried to achieve, this has often been attempted without having much information to assess the outcomes that actually occur.

For this reason, programs such as NSQIP (the National Surgical Quality Improvement Project) have been brought from the VA system into private and academic healthcare systems, to sample surgical outcomes and provide hospitals with benchmarks that can be achieved, as well as informing them where they rank in the overall results. Unfortunately, systems such as NSQIP are based on sampling a percentage of cases performed each week, but do not track all cases or all providers. Many cases are therefore not tracked in any way.

Certain centers have now established databases to track their own surgical outcomes. These are usually specific to certain surgical specialties, and provide an opportunity to perform quality improvement. These also have the added value of being useful tools for maintenance of certification and for clinical research.

Primary goals of this study:

We propose to establish a General Surgical Outcomes Quality Improvement Database (GSOD) which will track all cases performed by the Department of Surgery. This database will have several goals:

  1. The GSOD will be used to support the Mortality and Morbidity conference and directly support quality improvement and resident training.
  2. The GSOD will also be used for more advanced forms of quality improvement, for example being able to evaluate patients with prolonged length of stay so that cases can be defined and evaluated for specific risk factors or in-hospital events.
  3. By using hospital coded CPT and DRG codes, the GSOD will be able to accurately track cases performed by surgeons for maintenance of certification purposes.

All of these goals are related to quality improvement and assessment, and are considered "not human subjects research" under 45 CFR 46. In the future it is hoped that the GSOD will also be a powerful resource for formal research into surgical outcomes, and also for identification and tracking of cases in prospective and retrospective research trials. Future IRB submissions will be submitted for this purpose at a future time and this IRB submission therefore only addresses the quality improvement perspective of the GSOD.

  Eligibility

Ages Eligible for Study:   up to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients undergoinging surgical procedures in the Department of Surgery of University Hospitals of Cleveland.

Criteria

Inclusion Criteria:

  • All patients undergoing surgical procedures in the Department of Surgery of University Hospitals of Cleveland.

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622557

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Bridget Ermlich, BSN     216-844-3602     bridget.ermlich@uhhospitals.org    
Principal Investigator: Conor P. Delaney, MD, PhD            
Sub-Investigator: Jeffrey Ponsky, MD            
Sub-Investigator: Bridget Ermlich, BSN            
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
Principal Investigator: Conor P. Delaney, MD, PhD University Hospitals of Cleveland
  More Information

Responsible Party: University Hospitals of Cleveland ( Conor P. Delaney, MD, PhD )
Study ID Numbers: 04-07-18
Study First Received: February 11, 2008
Last Updated: November 4, 2008
ClinicalTrials.gov Identifier: NCT00622557  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Polyps
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm
Diverticulitis
Digestive System Diseases
Crohn Disease
Gastrointestinal Neoplasms
Gastroenteritis
Rectal cancer
Colitis
Colonic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009