Severe Complications Triplicate the Costs of Major Surgical Procedures - Full Text View

Sponsor:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00855387

Purpose

The purpose of this study is to prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality.

Condition	Intervention
Major Surgical Procedures	Other: No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowel

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Surgical Complications Dramatically Influence Overall Cost of Major Surgical Procedures

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:

Clinical outcome (complications) In-hospital Costs [ Time Frame: inhospital; peri-operative ] [ Designated as safety issue: Yes ]

Enrollment:	1235
Study Start Date:	March 2009
Study Completion Date:	November 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Costs Patients collected consecutively for undergoing major surgical procedures(liver, bile duct, pancreas, small bowel, colo-rectal, gastric bypass resections).	Other: No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowel No additional intervention than the intended major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) comparing with costs

Detailed Description:

To prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality

Eligibility

Ages Eligible for Study:	12 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

A cohort study with 1235 patients including consecutive patients undergoing major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) in a single tertiary care center

Criteria

Inclusion Criteria:

Undergoing major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections)

Exclusion Criteria:

Missing data of in-hospital costs
Mortality

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855387

Locations

Switzerland
University Hospital of Zurich, Department of Visceral and Transplantation Surgery
Zurich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator:

René Vonlanthen, Dr. med.

Department of Visceral and Transplantation Surgery

More Information

No publications provided

Responsible Party:	University Hospital of Zurich ( R. Vonlanthen/Dr. med. )
Study ID Numbers:	StV 5-2009
Study First Received:	March 3, 2009
Last Updated:	November 25, 2009
ClinicalTrials.gov Identifier:	NCT00855387 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University of Zurich:

Clinical outcome (complications), in-hospital costs
The influence and impact of postoperative complications on in-hospital costs

Additional relevant MeSH terms:

Therapeutic Uses
Gastrointestinal Agents
Pancrelipase
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010