Colonoscope Insertion Trial Protocol
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 35 - 75 |
| Updated: | 12/3/2017 |
| Start Date: | June 2010 |
| End Date: | December 2011 |
Study to Examine Insertion of 2 Colonoscopes Trial
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.
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.
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.
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.
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)
We found this trial at
1
site
263 Farmington Ave
Farmington, Connecticut 06030
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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