Colon Investigation - Factors Determining Choice of Procedure

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. Identifier: NCT00423345
Recruitment Status : Unknown
Verified August 2012 by Stein Dahler, Sykehuset Telemark.
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2007
Last Update Posted : August 27, 2012
Information provided by (Responsible Party):
Stein Dahler, Sykehuset Telemark

Brief Summary:
Registration of patients referred for colon investigation by barium enema, CT colonography and colonoscopy in two hospitals and one radiology centre in Telemark, Norway, for a period of minimum six months. Indications, delay and results of procedure will be recorded.Hypothesis: Choice of procedure for colon investigation is not based solely on clinical indication, but factors like delay, patient preference, lack of knowledge about the the procedures by the referring physician may have a decisive influence. The study will also analyse the correlation between patients symptoms, clinical findings and laboratory results and major pathology findings by colon investigation. Further, delay from patient´s first symptoms to finally diagnosis by colon investigation will also be registered and analysed.

Condition or disease
Irritable Colon Colorectal Cancer Inflammatory Bowel Disease

Detailed Description:
see extensive protocol in Norwegian

Study Type : Observational
Actual Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Colon Investigation With Barium Enema, CT Colonography and Colonoscopy: A Prospective Registration of Indications, Delay and Procedure Results.
Study Start Date : October 2006
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Primary Outcome Measures :
  1. findings compared across investigation modes [ Time Frame: events by dec 2014 ]

Secondary Outcome Measures :
  1. Delayed diagnosis of CRC [ Time Frame: events by dec 2014 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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 referred for colonoscopy, barium enema or CT Colonoscopy and willing to participate

Inclusion Criteria:

  • Patients referred to colon investigation
  • Patients must be 18 years or older

Exclusion Criteria:

  • Patients not able to give a written consent

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 identifier (NCT number): NCT00423345

Telemark Radiology center
Porsgrunn, Telemark, Norway, 3900
Department of gastroentology, Telemark Hospital
Skien, Telemark, Norway, 3700
Department of gastroentology, Blefjell Hospital Notodden
Notodden, Norway, 3675
Sponsors and Collaborators
Sykehuset Telemark
Principal Investigator: Stein Dahler, MD Blefjell Hospital Notodden, Norway
Principal Investigator: Gert Huppertz-Hauss, MD Telemark Hospital, Norway
Principal Investigator: Arne R Hovland, MD Telemark Radiology center, Porsgrunn, Norway

Responsible Party: Stein Dahler, Physician, head of gastroenterology, Notodden Hospital, Sykehuset Telemark Identifier: NCT00423345     History of Changes
Other Study ID Numbers: 23504
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: August 27, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Colorectal Neoplasms
Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases, Functional