NCT02057562

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

2.6 years

First QC Date

February 5, 2014

Last Update Submit

November 18, 2016

Conditions

Colon AdenomaDiverticulosis

Keywords

AdenomaDiverticular diseaseDiverticulosisColorectal carcinomaPolyp

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    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 Outcomes (2)

  • Polyp detection rate

    up to one day

  • Frequency of colon diverticulosis

    up to one day

Study Arms (1)

Routine colonoscopy

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • indication for colonoscopy
  • age \>= 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rotkreuzklinikum München

München, Deutschland, 80634, Germany

Location

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

München, Deutschland, 81677, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colon polyps and mucosa

MeSH Terms

Conditions

DiverticulumAdenomaDiverticular DiseasesColorectal NeoplasmsPolyps

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Peter Klare, MD

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

    PRINCIPAL INVESTIGATOR

  • Peter Born, Prof. Dr.

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

    STUDY CHAIR

  • Stefan von Delius, MD

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 7, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2016

Study Completion

March 1, 2017

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

DE(2)