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| ID | Type | Description | Link |
|---|---|---|---|
| KOR-09-10 | Other Identifier | James J. Peters VA Medical Center |
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The annual incidence of colorectal cancer in the US during 2005 was approximately 150,000 cases and this neoplasm claimed 56,000 lives (American Cancer Society). Detection (and removal) of colonic polyps is now the central strategy in reducing the risk of colon cancer. Thus, failure to detect and remove small cancers and polyps can have dire consequences. Although it has not been shown that persons with spinal cord injury (SCI) have an increased risk of this disease, there is no reason to assume that the incidence after SCI would be less than that of the general population.
Colonoscopy would appear to be a better approach to colon cancer screening after SCI but may also be unreliable if bowel evacuation is unsatisfactory for complete large bowel visualization. Poor colonoscopic visualization is a major concern in persons with SCI because they have long-standing difficulty with evacuation (DWE) and might not respond in a predictable or satisfactory manner to the conventional bowel preparations used for colonoscopy. Furthermore, to the extent that bowel preparation for colonoscopy is unsatisfactory in persons with SCI, the putative benefits of colonoscopy in reducing colon cancer mortality may not be realized.
In the absence of effective regimens for bowel preparation in persons with SCI, we suspect that the documented benefits of screening colonoscopy in the able-bodied may not generalize to persons with SCI. Regardless, these observations support the need for improved bowel preparation approaches in persons with SCI. One such approach might involve the adjunctive administration of prokinetic drugs to standard practices. A prokinetic agent that might be beneficial in this context is neostigmine, an anticholinesterase inhibitor with prominent parasympathomimetic actions (stimulation of peristalsis) on the colon. We have studied neostigmine extensively in persons with SCI and have shown that, when given in combination with glycopyrrolate, this approach to stimulate bowel evacuation is safe and effective for bowel evacuation.
The annual incidence of colorectal cancer in the US during 2005 was approximately 150,000 cases and this neoplasm claimed 56,000 lives (American Cancer Society). Detection (and removal) of colonic polyps is now the central strategy in reducing the risk of colon cancer. Thus, failure to detect and remove small cancers and polyps can have dire consequences. Although it has not been shown that persons with spinal cord injury (SCI) have an increased risk of this disease, there is no reason to assume that the incidence after SCI would be less than that of the general population.
Colonoscopy would appear to be a better approach to colon cancer screening after SCI but may also be unreliable if bowel evacuation is unsatisfactory for complete large bowel visualization. Poor colonoscopic visualization is a major concern in persons with SCI because they have long-standing difficulty with evacuation (DWE) and might not respond in a predictable or satisfactory manner to the conventional bowel preparations used for colonoscopy. Furthermore, to the extent that bowel preparation for colonoscopy is unsatisfactory in persons with SCI, the putative benefits of colonoscopy in reducing colon cancer mortality may not be realized.
In the absence of effective regimens for bowel preparation in persons with SCI, we suspect that the documented benefits of screening colonoscopy in the able-bodied may not generalize to persons with SCI. Regardless, these observations support the need for improved bowel preparation approaches in persons with SCI. One such approach might involve the adjunctive administration of prokinetic drugs to standard practices. A prokinetic agent that might be beneficial in this context is neostigmine, an anticholinesterase inhibitor with prominent parasympathomimetic actions (stimulation of peristalsis) on the colon. We have studied neostigmine extensively in persons with SCI and have shown that, when given in combination with glycopyrrolate, this approach to stimulate bowel evacuation is safe and effective for bowel evacuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCI MoviPrep® (without NG) | No Intervention | (Spinal Cord Injury (SCI), glomerular filtration rate (GFR)<=50ml/min and SCI, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (without neostigmine plus glycopyrrolate [NG]) | |
| SCI PIEE (without NG) | No Intervention | (Spinal Cord Injury (SCI), glomerular filtration rate (GFR)>=50ml/min) pulsed irrigation enhanced evacuation [PIEE] (without neostigmine plus glycopyrrolate [NG]) | |
| Control MoviPrep® only | No Intervention | (Control, glomerular filtration rate (GFR)>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid (MoviPrep®) only (no NG) | |
| Control PIEE only | No Intervention | (Control, glomerular filtration rate (GFR)>=50ml/min), pulsed irrigation enhanced evacuation (PIEE) only (no NG) | |
| SCI MoviPrep® (with NG) | Experimental | (Spinal Cord Injury (SCI), glomerular filtration rate (GFR)<=50ml/min and SCI GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (with neostigmine plus glycopyrrolate [NG]) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neostigmine | Drug | Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Bowel Preparation | The quality of bowel preparation was determined by using the Ottawa Scale for bowel Evacuation. The range of this score is from 0 (perfectly clean and dry colon) to 14 ( a colon filled with stool and liquid). The right, mid and rectosigmoid colon were independently rated from 0-4 and fluid quality of entire colon was recorded with an additional score of 0-2. The total Ottawa Score is calculated by the sum of the independent scores of all three sections of the colon plus the fluid content. | 1-2 days following intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp Detection | The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation. | Time of Study |
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Inclusion Criteria:
1. SCI and able-bodied patients with clinical indication for a colonoscopic examination
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A. Korsten, MD | VA Medical Center, Bronx | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Bronx | The Bronx | New York | 10468 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25096918 | Derived | Lyons BL, Korsten MA, Spungen AM, Radulovic M, Rosman AS, Hunt K, Galea MD, Kornfeld SD, Yen C, Bauman WA. Comparison between pulsed irrigation enhanced evacuation and polyethylene glycol-electrolyte lavage solution for bowel preparation prior to elective colonoscopy in veterans with spinal cord injury. J Spinal Cord Med. 2015 Nov;38(6):805-11. doi: 10.1179/2045772314Y.0000000256. Epub 2014 Aug 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SCI MoviPrep® (Without NG) | (Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50 and SCI, GFR>=50) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (without neostigmine plus glycopyrrolate [NG]) |
| FG001 | SCI MoviPrep® (With NG) | (Spinal Cord Injury [SCI], glomerular filtration rate [GFR]<=50ml/min and SCI, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] (with neostigmine plus glycopyrrolate [NG]) Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established |
| FG002 | SCI PIEE (Without NG) | (Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (without neostigmine plus glycopyrrolate [NG]) |
| FG003 | SCI PIEE (With NG) | (Spinal Cord Injury [SCI], glomerular filtration rate [GFR]>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (with neostigmine plus glycopyrrolate [NG]) Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established |
| FG004 | Control MoviPrep® Only | (Control, GFR>=50ml/min) low-volume polyethylene glycol-electrolyte lavage with ascorbic acid [MoviPrep®] only (no neostigmine plus glycopyrrolate [NG]) |
| FG005 | Control PIEE Only | (Control, GFR>=50ml/min) PIEE only (no neostigmine plus glycopyrrolate [NG]) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SCI MoviPrep® (Without NG) | (SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG) |
| BG001 | SCI MoviPrep® (With NG) | (SCI, GFR<=50ml/min and GFR>=50ml/min) MoviPrep® (without NG) Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established |
| 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 | Quality of Bowel Preparation | The quality of bowel preparation was determined by using the Ottawa Scale for bowel Evacuation. The range of this score is from 0 (perfectly clean and dry colon) to 14 ( a colon filled with stool and liquid). The right, mid and rectosigmoid colon were independently rated from 0-4 and fluid quality of entire colon was recorded with an additional score of 0-2. The total Ottawa Score is calculated by the sum of the independent scores of all three sections of the colon plus the fluid content. | Posted | Mean | Standard Deviation | units on a scale | 1-2 days following intervention |
|
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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 | SCI MoviPrep® (Without NG) | (SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (without NG) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Investigations | This account was unrelated to study participation since the subject passed away years after their completion. However since the subject passed away while the the study was open, this event was recorded. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orthostatic Hypotension | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark A. Korsten, Chief of Gastroenterology | JJPVAMC National Center of Excellence for the Medical Consequeunces of Spinal Cord Injury | 718-584-9000 | 6753 | mark.korsten@va.gov |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| SCI PIEE (with NG) |
| Experimental |
(Spinal Cord Injury (SCI), glomerular filtration rate (GFR)>=50ml/min) pulsed irrigation enhanced evacuation (PIEE) (with neostigmine plus glycopyrrolate [NG]) |
|
| Ineligible due to GFR criteria |
|
| BG002 | SCI PIEE (Without NG) | (SCI, GFR>=50ml/min) PIEE ( without NG) |
| BG003 | SCI PIEE (With NG) | (SCI, GFR>=50ml/min) PIEE (with NG) Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established |
| BG004 | Control MoviPrep® Only | (Control, GFR>=50ml/min) MoviPrep® only (no NG) |
| BG005 | Control PIEE Only | (Control, GFR>=50ml/min) PIEE only (no NG) |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
(SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep® (withNG)
Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established
| OG002 | SCI PIEE (Without NG) | (SCI, GFR>=50ml/min) PIEE (without NG) Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established |
| OG003 | SCI PIEE (With NG) | (SCI, GFR>=50ml/min) PIEE (with NG) Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established |
| OG004 | Control MoviPrep® Only | (Control, GFR>=50ml/min) MoviPrep® only (no NG) |
| OG005 | Control PIEE Only | (Control, GFR>=50ml/min) PIEE only (no NG) |
|
|
| Secondary | Polyp Detection | The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation. | Posted | Mean | Standard Deviation | Number of polyps detected (numerical) | Time of Study |
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | SCI MoviPrep® (With NG) | (SCI, GFR<=50ml/min and GFR >=50ml/min) MoviPrep (with NG) Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established | 0 | 13 | 7 | 13 |
| EG002 | SCI PIEE (Without NG) | (SCI, GFR>=50ml/min) PIEE ( without NG) | 0 | 12 | 4 | 12 |
| EG003 | SCI PIEE (With NG) | (SCI, GFR>=50ml/min) PIEE (with NG) Neostigmine: Neostigmine will be administered in 20, 40, and 60mg doses until an individualized dose-response relationship is established | 0 | 12 | 10 | 12 |
| EG004 | Control MoviPrep® Only | (Control, GFR>=50ml/min) MoviPrep® only (no NG) | 1 | 28 | 4 | 28 |
| EG005 | SCI PIEE Only | (Control, GFR>=50ml/min) PIEE only (no NG) | 1 | 27 | 20 | 27 |
|
| Renal Problems | Renal and urinary disorders | Possibly related to the subject's participation in the study. |
|
| GI discomfort, bloating, distention | Gastrointestinal disorders | Symptoms reported by patients during study participation |
|
| Unable to complete preparation | Gastrointestinal disorders | Patients who were unable to successfully have a proper and complete bowel evacuation prior to colonoscopy |
|
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| D014947 | Wounds and Injuries |
| D009861 |
| Onium Compounds |