CA125 Levels and Other Inflammatory Markers in Laparoscop... | NCT01323361

Studies
CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair

NCT01323361

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Jan 28, 2013Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Hernia

Interventions

Laparoscopic ventral hernia repair

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010/29472	Other Identifier	Datainspectorate, Norway

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Mar 24, 2011

First Submission Date that Met QC Criteria

Mar 24, 2011

First Posted Date

Mar 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2013

Last Update Posted Date

Jan 28, 2013Estimated

Name	Class
Sykehuset Innlandet HF	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-immunosupressed	No Intervention	Normal population	Procedure: Laparoscopic ventral hernia repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic ventral hernia repair	Procedure	Patients operated with laparoscopic repair of ventral or incisional hernia	Non-immunosupressed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of variation in inflammatory markers related to "trauma" impact		6 weeks post surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital, Rikshospitalet		Oslo	Akershus	0424	Norway
Sykehuset Innlandet HF

Condition Browse Module

MeSH Terms

ID	Term
D006547	Hernia
D007249	Inflammation
D000072836	Surgical Wound
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided