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Sponsored by: |
University Hospitals of Cleveland |
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Information provided by: | University Hospitals of Cleveland |
ClinicalTrials.gov Identifier: | NCT00622557 |
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 |
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Colon Cancer Diverticulitis Colorectal Polyps Crohn's Disease Ulcerative Colitis Rectal Cancer |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | General Surgery Outcomes Database |
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 |
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Surgical |
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:
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.
Ages Eligible for Study: | up to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All patients undergoinging surgical procedures in the Department of Surgery of University Hospitals of Cleveland.
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Conor P. Delaney, MD, PhD | University Hospitals of Cleveland |
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 |
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 |
Neoplasms Pathologic Processes Neoplasms by Site |