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Prognosis of Colon Cancer. Clinical and Pathological-anatomical Factors Concerned With Radical Surgery


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Open (Enrolling)
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Colon Cancer

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Trial Information

Prognosis of Colon Cancer. Clinical and Pathological-anatomical Factors Concerned With Radical Surgery


1. Radical surgery. A detailed description of procedures for each location of tumor in the
large intestine is used. By following a given procedure for each location in the large
intestine, the number of lymph nodes can be analyzed for each location to find out if
this differs and if prognosis is affected by lymph node numbers according to tumor
site.

2. Markers. Different variables are examined for use in clinical judgment to make
treatment better as well as genetic experimental analyses for comparison with clinical
outcome to better understanding of clinical behavior.

3. Laparoscopic resections. The technical challenge of laparoscopic approach has been
compared with conventional surgery without any difference being observed in trials.
However, it should be compared with radical open surgery to compare best achievements
by using number of lymph nodes as well as outcome measures in the short and long term
(mortality).

4. Comorbidity, old age itself, type of surgery and perioperative care according to the so
called fast track surgery may all play a part in reducing perioperative morbidity and
mortality. A maximum 3% mortality should be aimed for.

5. Colon cancer usually metastasize to the liver and lungs. Surgical treatment of liver
metastases has been extensively studied and the prognosis has improved. Lung metastases
has not been given similar attention but the prognosis of those operated may be good
and equal that after liver surgery. The need for pulmonary resection and factors
associated with metastases and lung metastases in particular will be studied.


Inclusion Criteria:



- Malignant tumor (adenocarcinoma) of the large intestine (colon)

- Willingness to participate

Exclusion Criteria:

- No radical resection (R0) possible

- Unwilling to participate or medically unfit to undergo follow-up

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

3-year disease free survival (DFS)

Outcome Time Frame:

2007/10 - 2010/13

Safety Issue:

No

Principal Investigator

Karl Sondenaa, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Haraldsplass Deaconal Hospital, University of Bergen, Norway

Authority:

Norway: Data Protection Authority

Study ID:

Knut2009

NCT ID:

NCT00963352

Start Date:

January 2007

Completion Date:

December 2010

Related Keywords:

  • Colon Cancer
  • Colon cancer
  • Open surgery resection
  • Laparoscopic surgery resection
  • Morbidity
  • Mortality
  • Metastases
  • Oncology
  • Freedom of malignant disease recurrence
  • Safety of intervention open and laparoscopic
  • Examination of adverse markers
  • Development of metastases in lungs and other organs
  • Colonic Neoplasms

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