Colonoscope Insertion Trial Protocol

UConn Health

Status: Completed

Conditions: Colorectal Cancer

Treatments: Device: Control with standard colonoscope Olympus CF-H180; Device: Colonoscopy with Olympus Technically Improved Colonoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT01324882

10-246-1

1-642-01 (Other Identifier)

Details and patient eligibility

About

This research study is about determining how well a Technically Improved Colonoscope from Olympus works in helping the doctor in guiding the scope through the large bowel or colon. When a doctor performs a colonoscopy he guides or inserts the scope from the rectum to the appendix where the small bowel ends and the large bowel begins. There are points during this insertion where there are turns in the colon which can create a loop in the colonoscope. These loops can stretch the colon and create some discomfort and also require special maneuvers by the nurse or patient to help reduce or minimize the loop. Thus, reducing the looping will make it more comfortable for the patient and more efficient for screening for polyps. The purpose of the study is to examine this colonoscope and compare it to the traditional adult colonoscope (Olympus CF-H180). The investigators hypothesis is that this colonoscope will function better with regard to insertion of the scope from the rectum to the cecum.

Full description

There will be two arms to the study, the CF-H180 adult colonoscope (Control Arm) and the Olympus Technically Improved Colonoscope (Olympus). (Control Arm). In this protocol the investigators will randomize patients to either the adult colonoscope or to the Olympus Technically Improved Colonoscope (Olympus) arm. The name of the arm (CF-H180 adult colonoscope or Technically Improved Colonoscope) will be in a sealed envelope and opened by the nurse. The endoscopist will be blinded to the scope that will be used.

Enrollment: 57 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients presenting for outpatient colonoscopy between the ages of 35 and 75 years of age
• The patient population will be open. However, it is known that thin female patients (BMI < 25) and/or past history of diverticular disease and/or gynecological surgery and men & women who are tall (6'+) and patients with constipation are usually difficult candidates for a complete colonoscopy (retroflex in the cecum)
• Adequate bowel preparation
• The ability to provide informed consent

Exclusion criteria

• Women that are pregnant
• Patients with a past history of inflammatory bowel disease
• Patients with a past history of surgical resection (hemicolectomies, etc)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups

Study Arm

Experimental group

Description:

This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.

Treatment:

Device: Colonoscopy with Olympus Technically Improved Colonoscope

Control

Active Comparator group

Description:

This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.

Treatment:

Device: Control with standard colonoscope Olympus CF-H180