Implementation of Laparoscopy-assisted Surgery for Colon... | NCT01326065

Studies
Implementation of Laparoscopy-assisted Surgery for Colon Cancer

NCT01326065

Sponsor

Helse Stavanger HF

Status

Terminated

Last Update Posted

May 9, 2017Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Colon Cancer

Interventions

Not provided

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

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study had to be terminated due to lack of funding

Expanded Access Info

Start Date

Feb 2011Actual

Primary Completion Date

Mar 2012Actual

Completion Date

Feb 2017Actual

First Submitted Date

Feb 27, 2011

First Submission Date that Met QC Criteria

Mar 29, 2011

First Posted Date

Mar 30, 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

May 4, 2017

Last Update Posted Date

May 9, 2017Actual

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 purpose of this study is to study the implementation of laparoscopy-assisted surgery for cure of colon cancer in daily surgical practice.

Detailed Description

Prospective observational study of laparoscopy-assisted surgery for resectable colon cancer with regard to short term and long term outcomes

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

60Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long term outcome	overall survival and cancer specific survival, time to relapse	5 years

Secondary Outcomes

Measure	Description	Time Frame
Complications related to the surgical procedure	Anastomotic leaks; intra-abdominal infections; extra-abdominal complications, i.e. non-surgical site infections, cardiovascular events, death within 30 days after surgery	30 days
Quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >17 years
diagnosis of colon cancer either endoscopically, radiologically or histologically proven
No evidence of disseminated disease on CT scan
T1-3 according to preoperative CT scan
written informed consent to participate

Exclusion Criteria:

preoperative diagnosis of locally advanced tumor (T4)
suspicion of pathological lymph nodes outside anticipated resection area
contraindications against laparoscopic surgery, e.g. known bowel adhesions, anesthesiological concerns
lack of informed consent

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 submitted for curative resection of colon cancer to the Dept. of Surgery, Stavanger University Hospital. Catchment area of the hospital consists of a population of 300.000 inhabitants, with Stavanger UH as the only institution with surgical service

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hartwig Kørner, MD PhD	Helse Stavanger HF	Principal Investigator
Jens Christian Knapp, MD	Helse Stavanger HF	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stavanger University Hospital		Stavanger		N-4020	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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