Impact of Diverticular Disease on the Detection of Colon Adenomas

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02057562

Acronym

DECADE

Enrollment

1000

Registered

2014-02-07

Start date

2014-02-28

Completion date

2017-03-31

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Adenoma, Diverticulosis

Keywords

Adenoma, Diverticular disease, Diverticulosis, Colorectal carcinoma, Polyp

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Adenoma detection rate	up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)	After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks after colonoscopy ) accuracy of optical diagnosis can be determined

Secondary

Measure	Time frame	Description
Polyp detection rate	up to one day	a maximum of one day is expected for colonoscopy
Frequency of colon diverticulosis	up to one day	a maximum of one day is expected for colonoscopy

Countries

Germany

Outcome results