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

U

University of Erlangen-Nürnberg Medical School

Status

Unknown

Conditions

Polyps
Adenoma

Treatments

Diagnostic Test: Retroviewing endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT04107376
Ludwig Demling Endoscopy

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • screening colonoscopy
  • 18 years of age

Exclusion criteria

  • inflammatory bowel disease
  • inadequate bowel preparation

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Retroviewing endoscopy (RVE)
Experimental group
Description:
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.
Treatment:
Diagnostic Test: Retroviewing endoscopy
standard forward viewing endoscopy (SFVE)
Active Comparator group
Description:
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.
Treatment:
Diagnostic Test: Retroviewing endoscopy

Trial contacts and locations

1

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Central trial contact

Timo Rath, MD

Data sourced from clinicaltrials.gov

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