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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02057562
Other study ID # DECADE
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 5, 2014
Last updated November 18, 2016
Start date February 2014
Est. completion date March 2017

Study information

Verified date November 2016
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Benign adenomas of the colon have the potential to degenerate and become malignant. Therefore adenomatous polyps should be detected and resected during colonoscopy. Factors like advanced age and male gender are associated with the detection of adenomas. The same epidemiological pattern can be found with regard to colon diverticula. Furthermore, western world countries report higher incidences of both colorectal carcinoma as well as diverticular disease. It is not known whether a correlation exists between both entities. Some recent data have postulated higher adenoma detection rates in patients with concomitant diverticular disease (Rondagh EJ et al. Eur J Gastroenterol Hepatol. 2011; 23:1050-5. Kieff BJ et al. Am J Gastroenterol 2004; 99: 2007-11). If a positive correlation could be found this would possibly affect recommendations regarding colonoscopy surveillance intervals for patients with and without diverticular disease. The investigators therefore plan to conduct the following trial.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date March 2017
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- indication for colonoscopy

- age >= 18 years

Exclusion Criteria:

- pregnant women

- patients denying written consent

- indication for colonoscopy: familial adenomatous polypose

- indication for colonoscopy: inflammatory bowel disease

- indication for colonoscopy: previously known colon polyp/adenoma/carcinoma

- history of colon surgery

- contraindication for resection of polyps

- American Society of Anesthesiologists (ASA) class IV, V or VI

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München München Deutschland
Germany Rotkreuzklinikum München München Deutschland

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adenoma detection rate After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks after colonoscopy ) accuracy of optical diagnosis can be determined up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks) No
Secondary Polyp detection rate a maximum of one day is expected for colonoscopy up to one day No
Secondary Frequency of colon diverticulosis a maximum of one day is expected for colonoscopy up to one day No
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