Impact of Diverticular Disease on the Detection of Colon Adenomas

Colon Adenoma Clinical Trial

— DECADE  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02057562
• Other study ID #: DECADE
• 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

• Adenoma
• Colon Adenoma
• Diverticulosis
• Diverticulum

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