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CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair

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. Identifier: NCT01323361
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : January 28, 2013
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Jan Lambrecht, Oslo University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Hernia Procedure: Laparoscopic ventral hernia repair Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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
Study Start Date : April 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
No Intervention: Non-immunosupressed
Normal population
Procedure: Laparoscopic ventral hernia repair
Patients operated with laparoscopic repair of ventral or incisional hernia

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01323361

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Oslo University Hospital, Rikshospitalet
Oslo, Akershus, Norway, 0424
Sykehuset Innlandet HF
Gjøvik, Oppland, Norway, 2819
Sponsors and Collaborators
Oslo University Hospital
Sykehuset Innlandet HF
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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
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Responsible Party: Jan Lambrecht, MD, Oslo University Hospital Identifier: NCT01323361    
Other Study ID Numbers: 2010/3264-1 (REK)
2010/29472 ( Other Identifier: Datainspectorate, Norway )
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013
Keywords provided by Jan Lambrecht, Oslo University Hospital:
Additional relevant MeSH terms:
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Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal