Length of Tumour Feeding Artery After Colon Cancer Surgery | NCT02164149

Studies
Length of Tumour Feeding Artery After Colon Cancer Surgery

NCT02164149

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Jun 16, 2014Estimated

Enrollment

65Estimated

Phase

Not provided

Conditions

Colon Cancer

Interventions

Patients with primary colon cancer

Countries

Denmark

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

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Nov 2014Estimated

Completion Date

Nov 2015Estimated

First Submitted Date

Jun 2, 2014

First Submission Date that Met QC Criteria

Jun 12, 2014

First Posted Date

Jun 16, 2014Estimated

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

Jun 12, 2014

Last Update Posted Date

Jun 16, 2014Estimated

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 quality of colon cancer surgery is highly debated these years since the mortality of the disease is not declining markedly. Surgery is the main treatment of colon cancer and during surgery it is very important for the surgeon to remove the tumour and all potential ways of tumour spread. As colon cancer first of all spreads to the nearby lymph nodes lying along the tumour feeding artery the surgeon aims to cut the vessel as central as possible. This means that all of the tumour feeding artery should have been removed after surgery.

In this study the investigators want to measure the length of the tumour feeding artery after surgery as a quality control of the surgery. The investigators hypothesize that the artery will be shorter than 5 mm.

The investigators wish to CT scan all patients two days after colon cancer surgery and afterwards measure then length of the artery on the images. This study will not inflict with the normal routine for patient information and treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Quality of colon cancer surgery		Patients with primary colon cancer	Other: Patients with primary colon cancer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients with primary colon cancer	Other	CT scan two days after surgery	Quality of colon cancer surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CT scan after colon cancer surgery. The length of the tumour feeding artery will be measured on the images.	Patients will have an extra CT scan two days after surgery.	6 to 9 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary colon cancer

Exclusion Criteria:

Kidney failure, allergy to contrast, pregnancy

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

All patients over 18 years with primary colon cancer, who are to have surgery at Randers Regional Hospital, Denmark.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ditte Munkedal, MD	Contact	+45 7846 7710		Ditte.Munkedal@viborg.rm.dk
Soren Laurberg, Professor	Contact	+45 7846 7715		soeren.laurberg@aarhus.rm.dk

Overall Officials

Name	Affiliation	Role
Soren Laurberg, Professor	Aarhus University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital	Recruiting	Aarhus		8000	Denmark

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