Impact of Diverticular Disease on the Detection of Colon Adenomas (DECADE)

November 18, 2016 updated by: Dr. Peter Klare, Technical University of Munich
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Deutschland
      • München, Deutschland, Germany, 80634
        • Rotkreuzklinikum Munchen
      • München, Deutschland, Germany, 81677
        • II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients receiving routine colonoscopy at the both study centers are eligible for participation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: 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
up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyp detection rate
Time Frame: up to one day
a maximum of one day is expected for colonoscopy
up to one day
Frequency of colon diverticulosis
Time Frame: up to one day
a maximum of one day is expected for colonoscopy
up to one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 5, 2014

First Posted (Estimate)

February 7, 2014

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DECADE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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