Chromoendoscopy of the Colon After Oral Administration of Indigo Carmine

Not Applicable

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Indigo Carmine

• Registration Number: NCT01914445
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

The purpose of this study is to examine whether oral administration of Indigo Carmine together with Polyethylene Glycol (PEG), the usual colon preparatory solution, can be used instead of staining during the examination itself.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-07
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-07-31
• Last Update Submitted: 2013-07-31
• Study Start: 2013-08
• Study First Posted: 2013-08-02
• Last Update Posted: 2013-08-02
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients suffering from Inflammatory Bowel Disease
• Patients under surveillance for Disease-Associated Lesions and Masses (DALM)

Exclusion Criteria

• All others

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indigo Carmine	Indigo Carmine	Indigo Carmine (2 mg per kilo) and 2nd half of PEG dose will be orally administered to patients prior to colonoscopy.

Primary Outcome Measures

Name	Time	Method
Efficacy of Indigo Carmine during oral administration	One hour	The efficacy of Indigo Carmine in staining tissues to better characterize, delineate, and highlight the gastrointestinal mucosa will be determined during the colonoscopic examination. Biopsies will be taken from suspicious lesions.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel