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
  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:


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
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: 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 August 28, 2014