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

Completed

• Conditions: Colon Adenoma

• Registration Number: NCT02819492
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-06-30
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-08
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate in the proximal colon	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

Name	Time	Method
Polyp detection rate	up to one day	a maximum of one day is expected for colonoscopy procedures

Trial Locations

Locations (1)

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munich, Germany