A Comparison of Methods to Detect Polyps During Colonoscopy

NeuroTherapia, Inc.

Status: Completed

Conditions: Colorectal Cancer

Treatments: Procedure: Dual Inspection Colonoscopy; Procedure: Standard Inspection Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01025960

09-786

Details and patient eligibility

About

Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer deaths in western countries. Colonoscopy is a preferred colorectal screening modality since it has both diagnostic and therapeutic capability. Detection and removal of polyps at colonoscopy decreases the incidence and mortality from colorectal cancer.

Typical practice is to insert the colonoscope rapidly until it reaches the cecum (a pouch-like portion of the intestines, where the large bowel and the small bowel meet). The physician then withdraws the colonoscope slowly and looks for any polyps or abnormalities within the large bowel. The purpose of this study is to compare this standard practice to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.

Enrollment: 768 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patients
• Patients able to provide an informed consent
• Patients undergoing colonoscopy

Exclusion criteria

• Pregnant women
• Patients with Familial Adenomatous Polyposis Syndromes (FAP)
• Patients with Hereditary Non-polyposis Colon Cancer Syndrome (HNPCC)
• Patients who have undergone previous surgical resection of the colon
• Patients who have been diagnosed with inflammatory bowel disease

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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768 participants in 2 patient groups

Standard Inspection Colonoscopy

Other group

Description:

The colonoscope will be inserted rapidly to reach the cecum. Inspection of the large bowel will occur during the withdrawal of the colonoscope.

Treatment:

Procedure: Standard Inspection Colonoscopy

Dual Inspection Colonoscopy

Active Comparator group

Description:

The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.

Treatment:

Procedure: Dual Inspection Colonoscopy