Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)

PHASE4CompletedINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

May 16, 2013

Primary Completion Date

June 30, 2017

Study Completion Date

September 30, 2017

Conditions
Colorectal Neoplasms
Interventions
DRUG

Indigo carmine

0.008% indigo carmine in water is used as a surface contrast agent to enhance visualization of diminutive polyps (adenoma) during screening colonoscopy

PROCEDURE

water (exchange) method

Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions.

PROCEDURE

water (exchange) plus dye method

Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions

PROCEDURE

air method

The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated.

Trial Locations (1)

95655

VA Northern California Health Care System, Mather, CA, Sacramento

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT01607255 - Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT) | Biotech Hunter | Biotech Hunter