Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Secondary endpoints:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dye staining | Experimental | Food grade dye mucosal staining |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food grade dye mucosal staining | Dietary Supplement | mucosal staining with food grade dye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of mucosal staining | Assessment of mucosal staining by questionnaire | Day of scheduled endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment related adverse events | Day of scheduled endoscopy and within 3 days after colonoscopy | |
| Number of patients with detected adenomas | Day of scheduled endoscopy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Ellrichmann, MD | Contact | 00494315972075 | mark.ellrichmann@uksh.de | |
| Stefan Schreiber, Prof. | Contact | 00494315971272 | s.schreiber@mucosa.de |
| Name | Affiliation | Role |
|---|---|---|
| Mark Ellrichmann, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Stefan Schreiber, Prof. | University Hospital Schleswig-Holstein | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Schleswig-Holstein, Campus Kiel | Recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided