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Impact of Microparticles on Postoperative Complications in Surgical Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00677781
First Posted: May 15, 2008
Last Update Posted: September 7, 2011
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.
Information provided by:
University of Bern
  Purpose
Microparticles are cellular fragments which are released actively or passively under conditions of inflammation and stress. The impact of surgical operations on quantity and quality of microparticles remains unknown. In this observatory study we investigate quantitative and qualitative aspects of microparticles during cardiac and abdominal operations.

Condition
Neoplasm, Hepatic Pancreatic Neoplasms Colorectal Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Microparticles on Inflammatory Responses During Visceral and Cardiac Surgery

Further study details as provided by University of Bern:

Primary Outcome Measures:
  • Postoperative morbidity [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Hospital stay [ Time Frame: 30 days ]
  • Mortality [ Time Frame: 30 days ]

Biospecimen Retention:   Samples Without DNA
Serum

Enrollment: 108
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
F64
We investigate a cohort of 20 consecutive patients undergoing hepatic or pancreatic surgery (Pilot study)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing cardiac or hepatobiliary or colorectal surgery. Setting: university hospital.
Criteria

Inclusion Criteria:

  • Patients undergoing cardiac or abdominal operations with a minimum expected operative time of 2 hours

Exclusion Criteria:

  • Laparoscopic operations
  • emergency operations
  Contacts and Locations
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): NCT00677781


Locations
Switzerland
Department of visceral and transplant surgery, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
Investigators
Principal Investigator: Guido Beldi, MD Bern University Hospital
  More Information

Publications:

Responsible Party: Guido Beldi, MD, Department of visceral and transplant surgery, Inselspital Bern, Switzerland
ClinicalTrials.gov Identifier: NCT00677781     History of Changes
Other Study ID Numbers: KEK251_07
First Submitted: May 8, 2008
First Posted: May 15, 2008
Last Update Posted: September 7, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Postoperative Complications
Pancreatic Neoplasms
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases