Attenuated Inflammatory Response in Laparoscopic Colon Su... | NCT01419431

Studies
Attenuated Inflammatory Response in Laparoscopic Colon Surgery

NCT01419431

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Dec 16, 2011Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Regulation of Inflammatory Response

Interventions

Laparoscopic resection

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
SOCS-3-202008	Other Grant/Funding Number	OUS-SOCS3

Status Module

Record Verification Date

Dec 2011

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

Jan 2007

Primary Completion Date

Nov 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jul 18, 2011

First Submission Date that Met QC Criteria

Aug 17, 2011

First Posted Date

Aug 18, 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

Dec 15, 2011

Last Update Posted Date

Dec 16, 2011Estimated

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

Pro-inflammatory responses following laparoscopic surgery.

Detailed Description

Blood samples from 20 patient with colon cancer collected before and in 3 days following laparoscopic surgery. Analyzed for inflammatory cytokines and corresponding SOCS3 mRNA.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colon cancer patients		Laparoscopic resection	Procedure: Laparoscopic resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic resection	Procedure	Inflammatory response in laparoscopic surgery	Colon cancer patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inflammatory values for laparoscopic resection for colon cancer.	Corresponding values of SOCS3 mRNA copared to inflammatory cytokines in patients with laparoscopic resection for colon cancer.	3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:Colon cancer stage I-III -

Exclusion Criteria:Colon cancer stage IV

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

Colon cancer stage I-III

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dag T. Førland, MD	OUS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0407	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided