Impact of Diverticular Disease on the Detection of Colon Adenomas

• Conditions: Diverticulosis; Colon Adenoma

• Registration Number: NCT02057562
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-07
• Primary Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Rotkreuzklinikum München; 🇩🇪 München, Deutschland, Germany

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 München, Deutschland, Germany