NCT01323361

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

March 24, 2011

Last Update Submit

January 25, 2013

Conditions

Hernia

Keywords

inflammationlaparoscopyherniaincisionaltrauma

Outcome Measures

Primary Outcomes (1)

  • Level of variation in inflammatory markers related to "trauma" impact

    6 weeks post surgery

Study Arms (1)

Non-immunosupressed

NO INTERVENTION

Normal population

Procedure: Laparoscopic ventral hernia repair

Interventions

Laparoscopic ventral hernia repairPROCEDURE

Patients operated with laparoscopic repair of ventral or incisional hernia

Non-immunosupressed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults admitted for ventral or incisional hernia repair

You may not qualify if:

  • Loss-of-domain
  • ASA above III
  • Liver failure
  • Abnormal CA-125 prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oslo University Hospital, Rikshospitalet

Oslo, Akershus, 0424, Norway

Location

Sykehuset Innlandet HF

Gjøvik, Oppland, 2819, Norway

Location

MeSH Terms

Conditions

HerniaInflammationSurgical WoundWounds and Injuries

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • jan r lambrecht, md

    Sykehuset Innlandet HF

    STUDY DIRECTOR

  • ole m øyen, Dr. Med.

    Oslo University Hospital

    STUDY CHAIR

  • erik trondsen, Dr. Med.

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 25, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

NO(2)