NCT02631798

Chromocolonoscopy With Food-grade Dyes

Mucosal Staining After Oral Administration of Food Grade Dyes in Subjects Undergoing Outpatients Colonoscopy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	Food grade dye mucosal staining	mucosal staining with food grade dye

Timeline

• Start date: 2015-12-01
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2015-12-16
• Last updated: 2022-07-01

Locations

1 site across 1 country: Germany