ClinicalTrials.gov
ClinicalTrials.gov Menu

Severe Complications Triplicate the Costs of Major Surgical Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00855387
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : November 26, 2009
Sponsor:
Information provided by:
University of Zurich

Brief Summary:
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 or disease Intervention/treatment
Major Surgical Procedures Other: No additional intervention than the intended major surgery in pancreas, liver, colorectal, gastric bypass and small bowel

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

Study Type : Observational
Actual Enrollment : 1235 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Surgical Complications Dramatically Influence Overall Cost of Major Surgical Procedures
Study Start Date : March 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Clinical outcome (complications) In-hospital Costs [ Time Frame: inhospital; peri-operative ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: R. Vonlanthen/Dr. med., University Hospital of Zurich
ClinicalTrials.gov Identifier: NCT00855387     History of Changes
Other Study ID Numbers: StV 5-2009
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: November 26, 2009
Last Verified: November 2009

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:
Pancrelipase
Pancreatin
Gastrointestinal Agents