Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02819492
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : April 11, 2017
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

Layout table for study information
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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.

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 identifier (NCT number): NCT02819492

Layout table for location information
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Munich, Germany, 81677
Sponsors and Collaborators
Technische Universität München

Layout table for additonal information
Responsible Party: Technische Universität München 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:
Observation Time
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type