Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Intervention: Indigo carmine; water (exchange) method; water (exchange) plus dye method; air method
Intervention description: 0.008% indigo carmine in water is used as a surface contrast agent to enhance visualization of diminutive polyps (adenoma) during screening colonoscopy; 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.; 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; 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 480.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adenoma detection; screening colonoscopy; water exchange method; chromoendoscopy

Summary:

      Adenoma detection rate (ADR) is a quality indicator of colonoscopy performed for colorectal
      cancer screening. Population studies have shown that traditional air colonoscopy fails to
      eliminate post screening colonoscopy cancers or cancer mortality in the proximal colon. The
      investigators aim to establish the superior effectiveness of combining chromoendoscopy with
      the water exchange method in detecting more proximal diminutive adenomas during screening
      colonoscopy in sedated Veterans. An improved adenoma detection rate associated with optical
      colonoscopy will minimize the risk of missed lesions. The improvement may translate into a
      remedy for the limitations of screening colonoscopy in the proximal colon, e.g. a higher
      adenoma detection rate may minimize the burden of post screening colonoscopy interval
      colorectal cancers among the veteran population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  asymptomatic Veterans scheduled for first time screening colonoscopy and agree to be
             randomized will be enrolled.

        Exclusion Criteria:

          -  patients who decline to be randomized, non screening cases.