Impact of Diverticular Disease on the Detection of Colon Adenomas

NCT ID: NCT02057562

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Colon Adenoma Diverticulosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Routine colonoscopy

Patients receiving routine colonoscopy (for a multitude of indications) at the study centers are eligible for participation

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Dr. Peter Klare

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Klare, MD

Role: PRINCIPAL_INVESTIGATOR

II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany

Peter Born, Prof. Dr.

Role: STUDY_CHAIR

Innere Medizin II, Rotkreuzklinikum München, Nymphenburger Str. 163, München, Germany

Stefan von Delius, MD

Role: STUDY_DIRECTOR

II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany

Locations

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Rotkreuzklinikum München

München, Deutschland, Germany

Site Status

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

München, Deutschland, Germany

Site Status

Countries

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Germany

Other Identifiers

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DECADE

Identifier Type: -

Identifier Source: org_study_id

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