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CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01323361
First Posted: March 25, 2011
Last Update Posted: January 28, 2013
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.
Collaborator:
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Jan Lambrecht, Oslo University Hospital
  Purpose
The study aims to show variation in CA-125 and other inflammatory markers assumed to be a response to trauma and peritoneal inflammation in the perioperative period of laparoscopic ventral hernia repair

Condition Intervention
Hernia Procedure: Laparoscopic ventral hernia repair

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Multi-centre Observational Pilot-study for Evaluation of Variation in CA-125 and Other Inflammatory Markers in the Perioperative Period of Laparoscopic Ventral Hernia Repair

Resource links provided by NLM:


Further study details as provided by Jan Lambrecht, Oslo University Hospital:

Primary Outcome Measures:
  • Level of variation in inflammatory markers related to "trauma" impact [ Time Frame: 6 weeks post surgery ]

Enrollment: 10
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Non-immunosupressed
Normal population
Procedure: Laparoscopic ventral hernia repair
Patients operated with laparoscopic repair of ventral or incisional hernia

Detailed Description:
CA-125 and other inflammatory markers as body temperature, CRP, PCT, leucocytes and neutrophils measured pre- and post-operatively - correlated to trauma size i.e. area of dissection, mesh size, number of fixation points etc.
  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
Criteria

Inclusion Criteria:

  • Adults admitted for ventral or incisional hernia repair

Exclusion Criteria:

  • Loss-of-domain
  • ASA above III
  • Liver failure
  • Abnormal CA-125 prior to surgery
  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): NCT01323361


Locations
Norway
Oslo University Hospital, Rikshospitalet
Oslo, Akershus, Norway, 0424
Sykehuset Innlandet HF
Gjøvik, Oppland, Norway, 2819
Sponsors and Collaborators
Oslo University Hospital
Sykehuset Innlandet HF
Investigators
Study Director: jan r lambrecht, md Sykehuset Innlandet HF
Study Chair: ole m øyen, Dr. Med. Oslo University Hospital
Study Chair: erik trondsen, Dr. Med. Oslo University Hospital
  More Information

Responsible Party: Jan Lambrecht, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01323361     History of Changes
Other Study ID Numbers: 2010/3264-1 (REK)
2010/29472 ( Other Identifier: Datainspectorate, Norway )
First Submitted: March 24, 2011
First Posted: March 25, 2011
Last Update Posted: January 28, 2013
Last Verified: January 2013

Keywords provided by Jan Lambrecht, Oslo University Hospital:
inflammation
laparoscopy
hernia
incisional
trauma

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal