Clinical trial NCT01324882: Colonoscope Insertion Trial Protocol
Official title: Study to Examine Insertion of 2 Colonoscopes Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colonoscopy
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 57
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Time to Intubate the Cecum
timeFrame: 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.
measure: Intubation of Cecum
timeFrame: (day 1) Within time for performance of colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Joseph C Anderson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: