DECADE: Impact of Diverticular Disease on the Detection of Colon Adenomas

Sponsor

Technische Universität München (Other)

Overall Status

Unknown status

CT.gov ID

NCT02057562

Collaborator

(none)

1,000

Enrollment

Locations

36.9

Duration (Months)

500

Patients Per Site

13.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Adenoma Diverticulosis

Study Design

Study Type:

Observational

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Routine colonoscopy Patients receiving routine colonoscopy (for a multitude of indications) at the study centers are eligible for participation

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rotkreuzklinikum München	München	Deutschland	Germany	80634
2	II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München	München	Deutschland	Germany	81677

Sponsors and Collaborators

Technische Universität München

Investigators

Principal Investigator: Peter Klare, MD, II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
Study Chair: Peter Born, Prof. Dr., Innere Medizin II, Rotkreuzklinikum München, Nymphenburger Str. 163, München, Germany
Study Director: Stefan von Delius, MD, II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany