Impact of Microparticles on Postoperative Complications in Surgical Patients

This study has been completed.
Sponsor:
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00677781
First received: May 8, 2008
Last updated: September 5, 2011
Last verified: September 2011
  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

Resource links provided by NLM:


Further study details as provided by University of Bern:

Primary Outcome Measures:
  • Postoperative morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Chamouard, P., D. Desprez, B. Hugel, C. Kunzelmann, C. Gidon-Jeangirard, M. Lessard, R. Baumann, J.M. Freyssinet, and L. Grunebaum. 2005. Circulating cell-derived microparticles in Crohn's disease. Dig Dis Sci 50:574-580.

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
Study First Received: May 8, 2008
Last Updated: September 5, 2011
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on July 22, 2014