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| ID | Type | Description | Link |
|---|---|---|---|
| 1-642-01 | Other Identifier | UCHC |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope. |
|
| Control | Active Comparator | This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy with Olympus Technically Improved Colonoscope | Device | The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Intubate the Cecum | The time in seconds that it required to intubate the cecum as defined in our protocol. | 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. |
| 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. | (day 1) Within time for performance of colonoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph C Anderson, M.D. | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
No details to report
Patients were recruited from study initiation 1/31/2011 until June 30,2011. Patients were recruited from the clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Arm | This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope. |
| FG001 | Control | This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Arm | This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope. |
| BG001 | Control | This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Intubate the Cecum | The time in seconds that it required to intubate the cecum as defined in our protocol. | Posted | Mean | Standard Deviation | seconds | 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. |
|
An Average of 20 minutes, up to 30 minutes post procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Arm | This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Anderson | UConn Health Center | 8022959362 | 6003 | joseph.anderson@dartmouth.edu |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Control with standard colonoscope Olympus CF-H180 | Device | Standard colonoscopy using the adult scope, Olympus CF-H180. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Count of Participants | Participants | (day 1) Within time for performance of colonoscopy |
|
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Control | This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180. | 0 | 30 | 0 | 30 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |