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Side Specific Withdrawal Times for Colonoscopy: Impact on Adenoma Detection in the Proximal and Distal Colon (SNOWCAT)

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ClinicalTrials.gov Identifier: NCT02819492
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:
Adenoma detection in the main goal of screening colonoscopy. In order to detect adenomas it is mandatory to spend a long enough time investigating the colonic mucosa. A minimum observation time of 6 minutes has been proposed as a quality criterion for screening colonoscopy. However, different locations of the colon (proximal, distal) may require specific observation time periods. The colon can be divided into a proximal (right) and distal (left) part. Until now, it is unclear whether observation time has a significant impact on adenoma detection in both parts of the colon. The aim of this study therefore is to conduct a trial in which side-specific observation times and adenoma detection rates are measured in order to investigate this correlation in particular for the right colon.

Condition or disease
Colon Adenoma

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort
Routine colonoscopy Cohort
Patients receiving routine colonoscopy at the study site



Primary Outcome Measures :
  1. Adenoma detection rate in the proximal colon [ 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 -6 days) it can be determined whether the resected polyp contained adenomatous histology or not.


Secondary Outcome Measures :
  1. Polyp detection rate [ Time Frame: up to one day ]
    a maximum of one day is expected for colonoscopy procedures


Biospecimen Retention:   Samples Without DNA
Colon polyps


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving colonoscopy at the study site are eligible for participation.
Criteria

Inclusion Criteria:

  • indication for colonoscopy
  • age ≥ 40 years

Exclusion Criteria:

  • American Society of Anesthesiologists class IV or higher
  • pregnant women
  • indication for colonoscopy: inflammatory bowel disease
  • indication for colonoscopy: polyposis syndrome
  • indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
  • contraindication for polyp resection e.g. patients on warfarin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819492


Locations
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Germany
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Munich, Germany, 81677
Sponsors and Collaborators
Technische Universität München

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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02819492    
Other Study ID Numbers: SNOWCAT
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Technische Universität München:
Adenoma
Colonoscopy
Withdrawal
Proximal
Observation Time
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms