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Implementation of Laparoscopy-assisted Surgery for Colon Cancer

This study has been terminated.
(Study had to be terminated due to lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326065
First Posted: March 30, 2011
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Helse Stavanger HF
  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

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Long term outcome [ Time Frame: 5 years ]
    overall survival and cancer specific survival, time to relapse


Secondary Outcome Measures:
  • Complications related to the surgical procedure [ Time Frame: 30 days ]
    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 ]
    Quality of life as assessed by SF-36 questionary

  • Quality of the surgical specimen [ Time Frame: 14 days ]
    R0 resection or not; number of lymph nodes harvested


Enrollment: 60
Actual Study Start Date: February 2011
Study Completion Date: February 2017
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed Description:
Prospective observational study of laparoscopy-assisted surgery for resectable colon cancer with regard to short term and long term outcomes
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326065


Locations
Norway
Stavanger University Hospital
Stavanger, Norway, N-4020
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

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01326065     History of Changes
Other Study ID Numbers: SUH424503
First Submitted: February 27, 2011
First Posted: March 30, 2011
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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