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CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair

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ClinicalTrials.gov Identifier: NCT01323361
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : January 28, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
Hernia Procedure: Laparoscopic ventral hernia repair

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

Eligibility Criteria

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 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:
inflammation
laparoscopy
hernia
incisional
trauma

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