CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair

January 25, 2013 updated by: Jan Lambrecht, Oslo University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Oslo, Akershus, Norway, 0424
        • Oslo University Hospital, Rikshospitalet
    • Oppland
      • Gjøvik, Oppland, Norway, 2819
        • Sykehuset Innlandet HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Non-immunosupressed
Normal population
Procedure: Laparoscopic ventral hernia repair
Patients operated with laparoscopic repair of ventral or incisional hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of variation in inflammatory markers related to "trauma" impact
Time Frame: 6 weeks post surgery
6 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

March 24, 2011

First Posted (ESTIMATE)

March 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/3264-1 (REK)
  • 2010/29472 (OTHER: Datainspectorate, Norway)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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