Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps

Not Applicable

• Conditions: Polyps; Adenoma
• Interventions: Diagnostic Test: Retroviewing endoscopy

• Registration Number: NCT04107376
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

During standard colonoscopy a substantial number of colorectal polyps may be missed. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas. In this study it is tested whether a retro viewing endoscope can detect more colorectal polyps in comparisson to standard forward viewing endoscopy. Further, ppolyps detected, mean adenomas per Patient and withdrawal time are recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-26
• Last Update Submitted: 2019-09-26
• Study First Posted: 2019-09-27
• Last Update Posted: 2019-09-27
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• screening colonoscopy
• 18 years of age

Exclusion Criteria

• inflammatory bowel disease
• inadequate bowel preparation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retroviewing endoscopy (RVE)	Retroviewing endoscopy	Withdrawal in every colonic segment with SFV (standard forward view) followed by another withdrawal with the retroviewing endoscope. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes.
standard forward viewing endoscopy (SFVE)	Retroviewing endoscopy	Withdrawal in every colonic segment with SFV followed by another withdrawal with SFV. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes.

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	8 months	calculation of the adenoma detection rate in each arm

Secondary Outcome Measures

Name	Time	Method
Polyp detection rate	8 months	polyp detection rate in each arm
Withdrawal time	8 months	Withdrawal time in each arm
Mean number of adenomas per patient	8 months	Mean number of adenomas per patient in each arm

Trial Locations

Locations (1)

University Hospital Erlangen; 🇩🇪 Erlangen, Germany