Colonoscope Insertion Trial Protocol

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study to Examine Insertion of 2 Colonoscopes Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: Colonoscopy with Olympus Technically Improved Colonoscope
* Device: Control with standard colonoscope Olympus CF-H180


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope. | Device: Colonoscopy with Olympus Technically Improved Colonoscope<br>* The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope.<br>* Other names: Olympus Technically improved colonoscope;|
| Active Comparator: Control<br>This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180. | Device: Control with standard colonoscope Olympus CF-H180<br>* Standard colonoscopy using the adult scope, Olympus CF-H180.<br>* Other names: Olympus CF-H180;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Intubate the Cecum | The time in seconds that it required to intubate the cecum as defined in our protocol. | The outcome was measured during the colonoscopy which was Day 1. The duration of the study was the colonoscopy on Day 1. Once the colonoscopy was finished, the study was over. | 
| Intubation of Cecum | The ability of endoscopist to intubate the cecum with enough control of the tip to abut the appendix or begin to retroflex in the cecum. | (day 1) Within time for performance of colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy