Colorectal Cancer
Conditions
Keywords
colonoscopy
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.
Interventions
DEVICEColonoscopy with Olympus Technically Improved Colonoscope
The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope.
DEVICEControl with standard colonoscope Olympus CF-H180
Standard colonoscopy using the adult scope, Olympus CF-H180.
Sponsors
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Intubate the Cecum | 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. |
| Intubation of Cecum | (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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from study initiation 1/31/2011 until June 30,2011. Patients were recruited from the clinic.
Pre-assignment details
No details to report
Participants by arm
| Arm | Count |
|---|---|
| Study Arm This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope. | 27 |
| Control This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180. | 30 |
| Total | 57 |
Baseline characteristics
| Characteristic | Control | Study Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 8.3 | 55.7 years STANDARD_DEVIATION 6.8 | 55.85 years STANDARD_DEVIATION 7.5 |
| Region of Enrollment United States | 30 participants | 27 participants | 57 participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 30 |
| serious Total, serious adverse events | 0 / 27 | 0 / 30 |
Outcome results
Primary
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.
Time frame: (day 1) Within time for performance of colonoscopy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Arm | Intubation of Cecum | 27 Participants |
| Control | Intubation of Cecum | 29 Participants |
p-value: 1Fisher Exact
Primary
Time to Intubate the Cecum
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Arm | Time to Intubate the Cecum | 271 seconds | Standard Deviation 196 |
| Control | Time to Intubate the Cecum | 403 seconds | Standard Deviation 148 |