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

NCT02819492 | Completed

• 1 other identifier: SNOWCAT
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Adenoma

Keywords

Adenoma; Colonoscopy; Withdrawal; Proximal; Observation Time

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate in the proximal colon

  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.

  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 (1)

• Polyp detection rate

  up to one day

Study Arms (1)

Routine colonoscopy Cohort

Patients receiving routine colonoscopy at the study site

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving colonoscopy at the study site are eligible for participation.

You may qualify if:

• indication for colonoscopy
• age ≥ 40 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

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

Munich, 81677, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colon polyps

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: April 1, 2017
• Last Updated: April 11, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)