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| ID | Type | Description | Link |
|---|---|---|---|
| DVAMC-11-026 | Other Grant/Funding Number | MERIT |
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A randomized trial aimed at determining whether or not hemoclips are effective in preventing post-polypectomy bleeds on polyps that are 10mm in size or greater.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clip | Experimental | A clip is been placed at the polypectomy site. |
|
| No Clip | Placebo Comparator | A hemoclip is not placed at the site of the polypectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoclip Placement | Device | Placement of hemoclip at polypectomy site for polyps at least 1cm in size |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Delayed Post Polypectomy Bleeding | rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda A Feagins | VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31158369 | Derived | Feagins LA, Smith AD, Kim D, Halai A, Duttala S, Chebaa B, Lunsford T, Vizuete J, Mara M, Mascarenhas R, Meghani R, Kundrotas L, Dunbar KB, Cipher DJ, Harford WV, Spechler SJ. Efficacy of Prophylactic Hemoclips in Prevention of Delayed Post-Polypectomy Bleeding in Patients With Large Colonic Polyps. Gastroenterology. 2019 Oct;157(4):967-976.e1. doi: 10.1053/j.gastro.2019.05.003. Epub 2019 May 31. |
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Must have polyp 1cm in size removed during colonoscopy
11,182 enrolled into the study, but 10,084 screen failures as the majority did not have a polyp 1cm in size to meet criteria for randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Clip | A clip is been placed at the polypectomy site. Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size |
| FG001 | No Clip | A hemoclip is not placed at the site of the polypectomy. NO hemoclip placement: No hemoclip placement (placebo / sham) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clip | A clip is been placed at the polypectomy site. Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size |
| BG001 | No Clip | A hemoclip is not placed at the site of the polypectomy. NO hemoclip placement: No hemoclip placement (placebo / sham) |
| 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 Patients With Delayed Post Polypectomy Bleeding | rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery | Posted | Count of Participants | Participants | 30 days |
|
30 days
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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 | Clip | A clip is been placed at the polypectomy site. Hemoclip Placement: Placement of hemoclip at polypectomy site for polyps at least 1cm in size |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Feagins | VA | 214-587-1603 | linda.feagins@austin.utexas.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 | Sep 1, 2018 | Aug 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| NO hemoclip placement | Device | No hemoclip placement (placebo / sham) |
|
|
| South Texas Health Care System, San Antonio, TX |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Central Texas Veterans Health Care System, Temple, TX | Temple | Texas | 76504 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| smoking | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 547 |
| 25 |
| 547 |
| 5 |
| 547 |
| EG001 | No Clip | A hemoclip is not placed at the site of the polypectomy. NO hemoclip placement: No hemoclip placement (placebo / sham) | 1 | 551 | 21 | 551 | 2 | 551 |
| Chest pain / bradycardia | Cardiac disorders | Systematic Assessment |
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| Chronic renal failure | Renal and urinary disorders | Systematic Assessment |
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| Cerebrovascular accident / Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| Elective laminectomy | Surgical and medical procedures | Systematic Assessment |
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| Gallstones | Hepatobiliary disorders | Systematic Assessment |
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| Post-polypectomy bleed | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post-polypectomy coagulation syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
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| Rectal absess | Gastrointestinal disorders | Systematic Assessment |
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| Respiratory illnesses and diseases | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Unimportant bleed | Gastrointestinal disorders | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
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| Multiple falls | Injury, poisoning and procedural complications | Systematic Assessment |
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| Epistaxis | Blood and lymphatic system disorders | Systematic Assessment |
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| Unimportant bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | Systematic Assessment |
|
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