CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair
Primary Purpose
Hernia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Laparoscopic ventral hernia repair
Sponsored by
About this trial
This is an interventional basic science trial for Hernia focused on measuring inflammation, laparoscopy, hernia, incisional, trauma
Eligibility 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
Sites / Locations
- Oslo University Hospital, Rikshospitalet
- Sykehuset Innlandet HF
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Non-immunosupressed
Arm Description
Normal population
Outcomes
Primary Outcome Measures
Level of variation in inflammatory markers related to "trauma" impact
Secondary Outcome Measures
Full Information
NCT ID
NCT01323361
First Posted
March 24, 2011
Last Updated
January 25, 2013
Sponsor
Oslo University Hospital
Collaborators
Sykehuset Innlandet HF
1. Study Identification
Unique Protocol Identification Number
NCT01323361
Brief Title
CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair
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 Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Sykehuset Innlandet HF
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
inflammation, laparoscopy, hernia, incisional, trauma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-immunosupressed
Arm Type
No Intervention
Arm Description
Normal population
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ventral hernia repair
Intervention Description
Patients operated with laparoscopic repair of ventral or incisional hernia
Primary Outcome Measure Information:
Title
Level of variation in inflammatory markers related to "trauma" impact
Time Frame
6 weeks post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jan r lambrecht, md
Organizational Affiliation
Sykehuset Innlandet HF
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
ole m øyen, Dr. Med.
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
erik trondsen, Dr. Med.
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo University Hospital, Rikshospitalet
City
Oslo
State/Province
Akershus
ZIP/Postal Code
0424
Country
Norway
Facility Name
Sykehuset Innlandet HF
City
Gjøvik
State/Province
Oppland
ZIP/Postal Code
2819
Country
Norway
12. IPD Sharing Statement
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CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair
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