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NCT01323361 Clinical Trial

CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair

Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01323361
Other study ID # 2010/3264-1 (REK)
Secondary ID 2010/29472
Status Completed
Phase N/A
First received March 24, 2011
Last updated January 25, 2013
Start date April 2011
Est. completion date August 2012

Study information
Verified date January 2013
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Regional Ethics Commitee
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic ventral hernia repair
Patients operated with laparoscopic repair of ventral or incisional hernia

Locations
Country Name City State
Norway Sykehuset Innlandet HF Gjøvik Oppland
Norway Oslo University Hospital, Rikshospitalet Oslo Akershus

Sponsors (2)
Lead Sponsor Collaborator
Oslo University Hospital Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Level of variation in inflammatory markers related to "trauma" impact 6 weeks post surgery No
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