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Colonoscope Insertion Trial Protocol

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ClinicalTrials.gov Identifier: NCT01324882
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : August 23, 2013
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph Anderson, UConn Health

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Device: Colonoscopy with Olympus Technically Improved Colonoscope Device: Control with standard colonoscope Olympus CF-H180 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Study to Examine Insertion of 2 Colonoscopes Trial
Study Start Date : June 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Study Arm
This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
Device: Colonoscopy with Olympus Technically Improved Colonoscope
The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope.
Other Name: Olympus Technically improved colonoscope

Active Comparator: Control
This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
Device: Control with standard colonoscope Olympus CF-H180
Standard colonoscopy using the adult scope, Olympus CF-H180.
Other Name: Olympus CF-H180




Primary Outcome Measures :
  1. Time to Intubate the Cecum [ 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. ]
    The time in seconds that it required to intubate the cecum as defined in our protocol.

  2. Intubation of Cecum [ Time Frame: (day 1) Within time for performance of colonoscopy ]
    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.



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324882


Locations
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United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Investigators
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Principal Investigator: Joseph C Anderson, M.D. UConn Health

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Responsible Party: Joseph Anderson, Associate Prof (Adjunct), UConn Health
ClinicalTrials.gov Identifier: NCT01324882     History of Changes
Other Study ID Numbers: 10-246-1
1-642-01 ( Other Identifier: UCHC )
First Posted: March 29, 2011    Key Record Dates
Results First Posted: August 23, 2013
Last Update Posted: December 2, 2017
Last Verified: November 2017
Keywords provided by Joseph Anderson, UConn Health:
colonoscopy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases