search
Back to results

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
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hernia focused on measuring inflammation, laparoscopy, hernia, incisional, trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 24, 2011
Last Updated
January 25, 2013
Sponsor
Oslo University Hospital
Collaborators
Sykehuset Innlandet HF
search

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

Learn more about this trial

CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair

We'll reach out to this number within 24 hrs