Colon Investigation - Factors Determining Choice of Procedure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stein Dahler, Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT00423345
First received: January 17, 2007
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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
Irritable Colon
Colorectal Cancer
Inflammatory Bowel Disease

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Sykehuset Telemark:

Primary Outcome Measures:
  • findings compared across investigation modes [ Time Frame: events by dec 2014 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delayed diagnosis of CRC [ Time Frame: events by dec 2014 ] [ Designated as safety issue: No ]

Enrollment: 750
Study Start Date: October 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

see extensive protocol in Norwegian

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not able to give a written consent
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423345

Locations
Norway
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
Investigators
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
  More Information

No publications provided

Responsible Party: Stein Dahler, Physician, head of gastroenterology, Notodden Hospital, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT00423345     History of Changes
Other Study ID Numbers: 23504
Study First Received: January 17, 2007
Last Updated: August 24, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

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

ClinicalTrials.gov processed this record on October 01, 2014