Implementation of Laparoscopy-assisted Surgery for Colon Cancer

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

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

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:

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


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


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 identifier: NCT01326065

Contact: Hartwig Kørner, MD PhD +47 51518000
Contact: Jens Christian Knapp, MD +47 51518000

Stavanger University Hospital Recruiting
Stavanger, Norway, N-4020
Contact: Hartwig Kørner, MD PhD    +47 51518000   
Contact: Jens Christian Knapp, MD    +47 51518000   
Principal Investigator: Hartwig Kørner, MD PhD         
Sponsors and Collaborators
Helse Stavanger HF
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 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
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases processed this record on April 16, 2014