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CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair

This study has been completed.
Sponsor:
Collaborator:
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Jan Lambrecht, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01323361
First received: March 24, 2011
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  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: 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:

MedlinePlus related topics: Hernia Injuries Wounds
U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Level of variation in inflammatory markers related to "trauma" impact [ Time Frame: 6 weeks post surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 24, 2011
Last Updated: January 25, 2013
Health Authority: Norway: Regional Ethics Commitee

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

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

ClinicalTrials.gov processed this record on May 16, 2013