Colon Investigation - Factors Determining Choice of Procedure

NCT00423345 | Terminated DMC

• 1 other identifier: 23504
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 3

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.

Conditions

Irritable Colon; Colorectal Cancer; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• findings compared across investigation modes

  Findings by one investigation compared to other

  events by dec 2014

Secondary Outcomes (1)

• Delayed diagnosis of CRC

  events by dec 2014

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients not able to give a written consent

Sponsors & Collaborators

• Sykehuset Telemark: lead

Study Sites (3)

Telemark Radiology center

Porsgrunn, Telemark, 3900, Norway

Location

Department of gastroentology, Telemark Hospital

Skien, Telemark, 3700, Norway

Location

Department of gastroentology, Blefjell Hospital Notodden

Notodden, 3675, Norway

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Colorectal Neoplasms; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases; Gastroenteritis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, head of gastroenterology, Notodden Hospital

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 18, 2007
• Study Start: October 1, 2006
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)