Irritable ColonNCT00423345
Colon Investigation - Factors Determining Choice of Procedure
An observational study of Irritable Colon and Colorectal Cancer, run by Sykehuset Telemark at 3 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Colon, Colorectal Cancer, Inflammatory Bowel Disease
- How many people
- 750 participants
- Where
- 3 sitesNorway
- Study dates
- Oct 2006to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients referred for colonoscopy, barium enema or CT Colonoscopy and willing to participate
Who may be able to join
- Patients referred to colon investigation
- Patients must be 18 years or older
Who cannot join
- Patients not able to give a written consent
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Department of gastroentology, Blefjell Hospital Notodden
Notodden, 3675
Telemark Radiology center
Porsgrunn, Telemark, 3900
Department of gastroentology, Telemark Hospital
Skien, Telemark, 3700
About this study
Official title: Colon Investigation With Barium Enema, CT Colonography and Colonoscopy: A Prospective Registration of Indications, Delay and Procedure Results.
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.
Read the detailed description
see extensive protocol in Norwegian
- Medical subject headings
- Irritable Bowel Syndrome, Colorectal Neoplasms, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
findings compared across investigation modes
Findings by one investigation compared to other
Measured: events by dec 2014
Secondary outcomes (1)
Delayed diagnosis of CRC
Waiting times depending on accessibility of diagnostic methods
Measured: events by dec 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: One of the examinations (double contrast baium enema) became outdated in Norway
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Geir Hoff, Sykehuset Telemark
- Investigators
- Stein Dahler, MD, Principal investigator, Blefjell Hospital Notodden, NorwayGert Huppertz-Hauss, MD, Principal investigator, Telemark Hospital, NorwayArne R Hovland, MD, Principal investigator, Telemark Radiology center, Porsgrunn, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423345
- Sponsor's protocol ID
- 23504
- Status last verified
- Apr 2019
- First submitted
- 17 Jan 2007
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon Investigation With Barium Enema, CT Colonography and Colonoscopy: A Prospective Registration of Indications, Delay and Procedure Results.
- ClinicalTrials.gov ID
- NCT00423345
- Acronym / sponsor ID
- 23504
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: One of the examinations (double contrast baium enema) became outdated in Norway
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Study start
- Oct 2006
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
see extensive protocol in Norwegian
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred for colonoscopy, barium enema or CT Colonoscopy and willing to participate
Key inclusion criteria (2 listed)
- Patients referred to colon investigation
- Patients must be 18 years or older
Key exclusion criteria (1 listed)
- Patients not able to give a written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
findings compared across investigation modes
Time frame: events by dec 2014
Findings by one investigation compared to other
1 secondary outcome
Delayed diagnosis of CRC
Time frame: events by dec 2014
Results and safety
The study was stopped early (reason given: One of the examinations (double contrast baium enema) became outdated in Norway). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stein Dahler, MD principal investigator
Blefjell Hospital Notodden, Norway
Gert Huppertz-Hauss, MD principal investigator
Telemark Hospital, Norway
Arne R Hovland, MD principal investigator
Telemark Radiology center, Porsgrunn, Norway
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Colon and Colorectal Cancer, run by Sykehuset Telemark at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: One of the examinations (double contrast baium enema) became outdated in Norway). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
findings compared across investigation modes (time frame: events by dec 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.