HerniaNCT01323361
CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair
A study testing Laparoscopic ventral hernia repair in people with Hernia, run by Oslo University Hospital at 2 sites in Norway.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia
- What is being tested?
- Laparoscopic ventral hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesNorway
- Study dates
- Apr 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults admitted for ventral or incisional hernia repair
Who cannot join
- Loss-of-domain
- ASA above III
- Liver failure
- Abnormal CA-125 prior to surgery
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Sykehuset Innlandet HF
Gjøvik, Oppland, 2819
Oslo University Hospital, Rikshospitalet
Oslo, Akershus, 0424
About this study
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
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
Read the 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.
- Conditions
- Hernia
- Being tested
- Laparoscopic ventral hernia repair
- Keywords
- inflammation, laparoscopy, hernia, incisional, trauma
- Medical subject headings
- Hernia, Inflammation, Surgical Wound, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ventral hernia repairProcedure or surgery
Patients operated with laparoscopic repair of ventral or incisional hernia
| Study group | Role | What they receive |
|---|---|---|
| Non-immunosupressed | No intervention | Normal population Receives: Procedure: Laparoscopic ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of variation in inflammatory markers related to "trauma" impact
Measured: 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Responsible party
- Principal investigator, Jan Lambrecht, Oslo University Hospital
- Investigators
- jan r lambrecht, md, Study director, Sykehuset Innlandet HFole m øyen, Dr. Med., Study chair, Oslo University Hospitalerik trondsen, Dr. Med., Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323361
- Sponsor's protocol ID
- 2010/3264-1 (REK)
- Other IDs
- 2010/29472
- Status last verified
- Jan 2013
- First submitted
- 24 Mar 2011
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01323361
- Acronym / sponsor ID
- 2010/3264-1 (REK)
- Conditions
- Hernia
- Keywords
- inflammation, laparoscopy, hernia, incisional, trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-immunosupressed | No intervention | Procedure: Laparoscopic ventral hernia repairNormal population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults admitted for ventral or incisional hernia repair
Key exclusion criteria (4 listed)
- Loss-of-domain
- ASA above III
- Liver failure
- Abnormal CA-125 prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic ventral hernia repairPatients operated with laparoscopic repair of ventral or incisional hernia | Procedure or surgery | Non-immunosupressed |
Primary outcome
Level of variation in inflammatory markers related to "trauma" impact
Time frame: 6 weeks post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jan r lambrecht, md study director
Sykehuset Innlandet HF
ole m øyen, Dr. Med. study chair
Oslo University Hospital
erik trondsen, Dr. Med. study chair
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic ventral hernia repair in people with Hernia, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of variation in inflammatory markers related to "trauma" impact (time frame: 6 weeks post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.