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The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.
Although mortality from colon cancer is decreasing, it remains the second leading cause of cancer related death in the United States. There are multiple factors contributing to this decrease, such as increased awareness, improving screening techniques, etc.
Of the available modalities approved for colon cancer screening in the United States, colonoscopy is considered the gold standard. Colonoscopy has the advantage of being both diagnostic and therapeutic, allowing the removal of pre-cancerous polyps, before the polyps can transform into cancer. Colonic polyps can occur at any location from the rectum to the cecum. Colonoscopy has been shown to be more effective in decreasing incidence of cancer in the left colon but remains limited in the detection of right sided polyps /lesions 2. This difference based on location is thought to be due to several reasons. Typically the right side of the colon is less clean than the left side during colonoscopy, thereby impairing visualization of polyps. This problem has been overcome by incorporating a "split bowel preparation", which has not become standard of care. However, the problem of not being able to visualize polyps behind folds seen in the colon persists despite improvements in the quality of cleansing of the colon. Various endoscopic technologies have been introduced with the goal of assisting with the manipulation of such colonic folds, and thereby reducing chances of missing polyps behind fold. Two such colonoscope assisted devices including the distal transparent cap and the Endocuff endoscopic overtube.
The Endocuff overtube is a small device with flexible arms arranged in 2 rows. Each row has 8 short, soft arms projecting away from the device. These arms are used to peel back the colonic folds without causing physical damage to enable visualization behind colonic folds. The use of Endocuff overtube has shown promising results in terms of cecal intubation rate and time as well as adenoma detection rates 3.
The transparent cap attachment is a clear plastic device that fits at the end of the colonoscope and extends a short distance past the tip of the colonoscope. It aids in the manipulation of folds and in maintaining a suitable distance from the mucosa, with the goal of improving visualization. Although some studies comparing cap fitted colonoscopy to standard (non- attachment) colonoscopies have shown improved adenoma detection 4, others have shown no significant benefit 5.
Although, these devices have been compared with conventional colonoscopies (i.e without any distal attachment), to the investigator's knowledge, there are currently no studies that have compared these two distal colonoscope attachment devices head-to-head, and none has specifically evaluated effects on detection of right sided adenomas. Also, here at UCDavis, these devices are being used specifically in diagnostic colonoscopies for removal of large polyps and the choice of which specific device is used depends on level of comfort of the advanced endoscopist. The endoscopists participating in the investigators' study do not currently use these devices as part of their routine colonoscopies, thus it is important to provide head to head comparison of these devices to help guide management practice.
Therefore, the investigators' goal is to compare the Endocuff overtube assisted, transparent cap fitted, and non-cap fitted (standard) colonoscopy in patients presenting to UC Davis Medical Center for screening colonoscopies.
In addition, 2 of the 3 investigators will employ the water exchange method during for all arms of the trial, while the other investigator will employ the conventional air method of colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Standard colonoscopy - no distal colonoscope attachment will be used in this arm |
|
| Olympus transparent cap | Experimental | The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure |
|
| Medivators Endocuff | Experimental | The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olympus transparent cap | Device | distal colonoscope attachment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection Rate | The investigators will compare adenoma detection rate at completion of study across the 3 arms | Completion of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Proximal Adenoma Detection Rate | The investigators will compare proximal adenoma detection rate at completion of study across the 3 arms | Completion of procedure |
| Cecal Intubation Rate | The investigators will compare cecal intubation rate at completion of study across the 3 arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20042716 | Background | Brenner H, Hoffmeister M, Arndt V, Stegmaier C, Altenhofen L, Haug U. Protection from right- and left-sided colorectal neoplasms after colonoscopy: population-based study. J Natl Cancer Inst. 2010 Jan 20;102(2):89-95. doi: 10.1093/jnci/djp436. Epub 2009 Dec 30. | |
| 25861907 | Background | Pioche M, Matsumoto M, Takamaru H, Sakamoto T, Nakajima T, Matsuda T, Abe S, Kakugawa Y, Otake Y, Saito Y. Endocuff-assisted colonoscopy increases polyp detection rate: a simulated randomized study involving an anatomic colorectal model and 32 international endoscopists. Surg Endosc. 2016 Jan;30(1):288-95. doi: 10.1007/s00464-015-4208-8. Epub 2015 Apr 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | No distal colonoscope attachment will be used in this arm Control: No distal colonoscope attachments |
| FG001 | Olympus Transparent Cap | The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure Olympus transparent cap: distal colonoscope attachment |
| FG002 | Medivators Endocuff | The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure Medivators Endocuff: distal colonoscope attachment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | No distal colonoscope attachment will be used in this arm Control: No distal colonoscope attachments |
| BG001 | Olympus Transparent Cap | The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure Olympus transparent cap: distal colonoscope attachment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Adenoma Detection Rate | The investigators will compare adenoma detection rate at completion of study across the 3 arms | Posted | Number | percentage of adenomas detected | Completion of procedure |
|
8 months
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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 | Control | Standard colonoscopy - no distal colonoscope attachment will be used in this arm Control: No distal colonoscope attachments |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Gastrointestinal disorders | Systematic Assessment | Post polypectomy bleeding |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sooraj Tejaswi | University of California, Davis | 916-734-7215 | stejaswi@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2016 | May 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Medivators Endocuff |
| Device |
distal colonoscope attachment |
|
| Control | Device | No distal colonoscope attachments |
|
| Completion of procedure |
| Withdrawal Time | The investigators will compare colonoscopy withdrawal time rate at completion of study across the 3 arms | Completion of procedure |
| 22228167 | Background | Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum. 2012 Feb;55(2):218-25. doi: 10.1097/DCR.0b013e31823461ef. |
| 19251004 | Background | Harada Y, Hirasawa D, Fujita N, Noda Y, Kobayashi G, Ishida K, Yonechi M, Ito K, Suzuki T, Sugawara T, Horaguchi J, Takasawa O, Obana T, Oohira T, Onochi K, Kanno Y, Kuroha M, Iwai W. Impact of a transparent hood on the performance of total colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):637-44. doi: 10.1016/j.gie.2008.08.029. |
| BG002 | Medivators Endocuff | The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure Medivators Endocuff: distal colonoscope attachment |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| Alcoholic drinks per week | Mean | Standard Deviation | drinks per week |
|
| Diabetes | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure Medivators Endocuff: distal colonoscope attachment |
|
|
| Secondary | Proximal Adenoma Detection Rate | The investigators will compare proximal adenoma detection rate at completion of study across the 3 arms | Posted | Number | percentage of proximal adenomas | Completion of procedure |
|
|
|
| Secondary | Cecal Intubation Rate | The investigators will compare cecal intubation rate at completion of study across the 3 arms | Posted | Number | percentage of cecal intubation | Completion of procedure |
|
|
|
| Secondary | Withdrawal Time | The investigators will compare colonoscopy withdrawal time rate at completion of study across the 3 arms | Posted | Mean | Standard Deviation | minutes | Completion of procedure |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Olympus Transparent Cap | The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure Olympus transparent cap: distal colonoscope attachment | 0 | 42 | 0 | 42 | 0 | 42 |
| EG002 | Medivators Endocuff | The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure Medivators Endocuff: distal colonoscope attachment | 0 | 42 | 0 | 42 | 2 | 42 |
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