Colonoscope Insertion Trial Protocol
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colonoscopy with Olympus Technically Improved Colonoscope
Control with standard colonoscope Olympus CF-H180
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring colonoscopy
Eligibility Criteria
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)
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study Arm
Control
Arm Description
This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
Outcomes
Primary Outcome Measures
Time to Intubate the Cecum
The time in seconds that it required to intubate the cecum as defined in our protocol.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01324882
Brief Title
Colonoscope Insertion Trial Protocol
Official Title
Study to Examine Insertion of 2 Colonoscopes Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Arm
Arm Type
Experimental
Arm Description
This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
Intervention Type
Device
Intervention Name(s)
Colonoscopy with Olympus Technically Improved Colonoscope
Other Intervention Name(s)
Olympus Technically improved colonoscope
Intervention Description
The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope.
Intervention Type
Device
Intervention Name(s)
Control with standard colonoscope Olympus CF-H180
Other Intervention Name(s)
Olympus CF-H180
Intervention Description
Standard colonoscopy using the adult scope, Olympus CF-H180.
Primary Outcome Measure Information:
Title
Time to Intubate the Cecum
Description
The time in seconds that it required to intubate the cecum as defined in our protocol.
Time Frame
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.
Title
Intubation of Cecum
Description
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.
Time Frame
(day 1) Within time for performance of colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph C Anderson, M.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
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Colonoscope Insertion Trial Protocol
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