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Chromocolonoscopy With Food-grade Dyes

NCT02631798 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-07-01

No results posted yet for this study

Summary

Previous with methylene blue suggested that oral administration may be superior to conventional spray catheters. The main advantages claimed were better staining due to longer exposure to the dye, more uniform staining due to normal position of the intestines (during conventional chromocolonoscopy, patients are lying on one side), and a quicker and more comfortable procedure for the patients and endoscopy personnel.

Using food-grade dyes would enable higher dye loads and lower systemic side effects.

Food grade dyes will be administered orally during preparation with KleanPrep (total amount of 4 liters) in patients undergoing screening colonoscopy.

On day 1 patients will drink 3 l of the preparation solution, the last liter together with the last dose of dye will be administered 5 hours before scheduled colonoscopy.

Primary endpoints:

* quality of mucosal staining of colon (assessed by questionnaire)

Secondary endpoints:

* adenoma detection rate
* adverse events
* time of colonoscopy

Conditions

  • Chromoendoscopy

Interventions

DIETARY_SUPPLEMENT

Food grade dye mucosal staining

mucosal staining with food grade dye

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Mark Ellrichmann, MD · University Hospital Schleswig-Holstein

  • Stefan Schreiber, Prof. · University Hospital Schleswig-Holstein

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2023-06-30
Completion
2023-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02631798 on ClinicalTrials.gov