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This is a test in which a thin, black, flexible tube with a lighting system on the end is passed through the anus, into the rectum, in order to examine the large bowel or intestine, also called the colon. Colonoscopy is a very good test for examining the colon for polyps (warty growths that can turn into cancer), but it is not perfect. In fact, about 30% of polyps that are under 5 mm (about 1/5 of an inch) in size are missed during colonoscopy because they are hiding behind folds and bends in the colon. This research study is being done to determine if performing colonoscopy with a cap on the tip of the colonoscope will reduce the miss rate for polyps. A cap is a clear plastic hood that fits on the tip of the colonoscope and sticks out about 1/3 of an inch. During colonoscopy, the cap can be pressed against a fold or ridge in order to flatten it, so that the lining on the other side can be more easily seen. This may reduce the miss rate for colon polyps.
Patient will undergo tandem colonoscopy on the same day using propofol sedation. Patients will undergo one colonoscopy without the cap and a second colonoscopy with the cap on. We will endeavor to keep the total examination time equal between the groups and approximately six minutes. The order in which patients receive the two colonoscopies (i.e. cap or without cap first) will be randomized. Any polyps detected during the first colonoscopy will be removed during that procedure. During the withdrawal phase, the time for examination will be measured with a stopwatch, and the stopwatch will be stopped at any time a polyp is located and restarted when the polyp has been removed and retrieved. The stopwatch will also be stopped for suctioning fluid or washing debris from the colon surface. Any polyp detected and removed during the first colonoscopy will be counted as the detection for that procedure. During the second colonoscopy, all polyps will also be removed when detected. Any polyp identified and removed during the second procedure will be counted as a miss for the first procedure. All polyps will be sent separately for pathologic evaluation. The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point. The primary end point will be the miss rate for colonoscopy with the cap and colonoscopy without the cap.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial cap-fitted | Experimental | Initial cap-fitted colonoscopy for the first insertion |
|
| Initial regular | Active Comparator | Initial regular no cap on the end of the colonoscope for the first insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cap-fitted colonoscopy | Device | Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adenomas | Cap Fitted Colonoscopy (CFC) may significantly reduced miss rates for colorectal adenomas, specifically for small adenomas. This study is the first North American study of any design and the largest tandem study of CFC. CFC is a safe, simple, and inexpensive technology that could improve the reliability of colonoscopy in detecting colorectal neoplasia. Additional study of CFC in Western populations is warranted. | after the second colonoscopy is completed |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Examination Will be Measured With a Stopwatch, and the Stopwatch Will be Stopped at Any Time a Polyp is Located and Restarted When the Polyp Has Been Removed and Retrieved. | During the second colonoscopy, all polyps will also be removed when detected. Any polyp identified and removed during the second procedure will be counted as a miss for the first procedure. All polyps will be sent separately for pathologic evaluation. The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point. The primary end point will be the miss rate for colonoscopy with the cap and colonoscopy without the cap. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas K Rex, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20579648 | Derived | Hewett DG, Rex DK. Cap-fitted colonoscopy: a randomized, tandem colonoscopy study of adenoma miss rates. Gastrointest Endosc. 2010 Oct;72(4):775-81. doi: 10.1016/j.gie.2010.04.030. Epub 2010 Jun 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Cap First, Then Cap-fitted | no cap on the end of the colonoscope for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination. |
| FG001 | Initial Cap-fitted First, Then No Cap | Initial cap-fitted colonoscopy for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (14 Days) |
| |||||||||||||
| Washout (14 Days) |
| |||||||||||||
| Second Intervention (14days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Cap First, Then Cap Fitted | no cap on the end of the colonoscope for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination. |
| 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 | Number of Adenomas | Cap Fitted Colonoscopy (CFC) may significantly reduced miss rates for colorectal adenomas, specifically for small adenomas. This study is the first North American study of any design and the largest tandem study of CFC. CFC is a safe, simple, and inexpensive technology that could improve the reliability of colonoscopy in detecting colorectal neoplasia. Additional study of CFC in Western populations is warranted. | Posted | Number | First Colonoscopy number of adenomas | after the second colonoscopy is completed |
|
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Serious and/or other [non-serious] adverse events were not collected/assessed.
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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 | Initial Regular | no cap on the end of the colonoscope for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas K Rex, MD | Indiana University | 317-948-8741 | drex@iu.edu |
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| ID | Term |
|---|---|
| D011127 | Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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|
|
| after 2nd colonoscopy was completed in 24hrs |
| NOT COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Initial Cap-fitted First Then No Cap | Initial cap-fitted colonoscopy for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Initial Regular | no cap on the end of the colonoscope for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination. |
|
|
| Secondary | Time for Examination Will be Measured With a Stopwatch, and the Stopwatch Will be Stopped at Any Time a Polyp is Located and Restarted When the Polyp Has Been Removed and Retrieved. | During the second colonoscopy, all polyps will also be removed when detected. Any polyp identified and removed during the second procedure will be counted as a miss for the first procedure. All polyps will be sent separately for pathologic evaluation. The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point. The primary end point will be the miss rate for colonoscopy with the cap and colonoscopy without the cap. | Patients aged 50 years or older who were able to give informed consent and were scheduled for elective colonoscopy at IUH were eligible for enrollment. Exclusion criteria were American Society of Anesthesiologists class III or higher, previous surgical resection of the colon or rectum, inflammatory bowel disease, and current use of anticoagulants. | Posted | Mean | Standard Error | Minutes | after 2nd colonoscopy was completed in 24hrs |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Initial Cap-fitted | Initial cap-fitted colonoscopy for the first insertion Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination. | 0 | 0 | 0 | 0 |
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| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |