Clinical trial NCT02057562: Impact of Diverticular Disease on the Detection of Colon Adenomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Adenoma
Diverticulosis
Keywords: Adenoma
Diverticular disease
Diverticulosis
Colorectal carcinoma
Polyp
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving routine colonoscopy at the both study centers are eligible for participation.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adenoma detection rate
timeFrame: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)
Secondary outcomes:
measure: Polyp detection rate
timeFrame: up to one day
measure: Frequency of colon diverticulosis
timeFrame: up to one day
Other outcomes:
Locations:
city: München
country: Germany
facility: Rotkreuzklinikum München
state: Deutschland
city: München
country: Germany
facility: II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
state: Deutschland
Study officials:
affiliation: II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
name: Peter Klare, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Innere Medizin II, Rotkreuzklinikum München, Nymphenburger Str. 163, München, Germany
name: Peter Born, Prof. Dr.
role: STUDY_CHAIR
affiliation: II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
name: Stefan von Delius, MD
role: STUDY_DIRECTOR
References: