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Implementation of Laparoscopy-assisted Surgery for Colon Cancer

This study is currently recruiting participants.
Verified August 2012 by Helse Stavanger HF
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01326065
First received: February 27, 2011
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition
Colon Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implementation of Laparoscopy-assisted Surgery for Colon Cancer. A Prospective Population-based Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Long term outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    overall survival and cancer specific survival, time to relapse


Secondary Outcome Measures:
  • Complications related to the surgical procedure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Anastomotic leaks; intra-abdominal infections; extra-abdominal complications, i.e. non-surgical site infections, cardiovascular events, death within 30 days after surgery

  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Quality of life as assessed by SF-36 questionary

  • Quality of the surgical specimen [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    R0 resection or not; number of lymph nodes harvested


Estimated Enrollment: 270
Study Start Date: February 2011
Estimated Study Completion Date: February 2017
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326065

Contacts
Contact: Hartwig Kørner, MD PhD +47 51518000 hartwig.korner@kir.uib.no
Contact: Jens Christian Knapp, MD +47 51518000 knjc@sus.no

Locations
Norway
Stavanger University Hospital Recruiting
Stavanger, Norway, N-4020
Contact: Hartwig Kørner, MD PhD     +47 51518000     koerner@online.no    
Contact: Jens Christian Knapp, MD     +47 51518000     knjc@sus.no    
Principal Investigator: Hartwig Kørner, MD PhD            
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Principal Investigator: Hartwig Kørner, MD PhD Helse Stavanger HF
Study Chair: Jens Christian Knapp, MD Helse Stavanger HF
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01326065     History of Changes
Other Study ID Numbers: SUH424503
Study First Received: February 27, 2011
Last Updated: August 29, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013