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Trial Objectives
The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set:
overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEEA Stapler | Experimental | hemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemorrhoidopexy | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Uneventful Creation of a Functional Staple Line at First Firing of Device | Successful creation of staple line at first firing of device during hemorrhoidopexy | about 20 minutes for procedure |
| Measure | Description | Time Frame |
|---|---|---|
| OR Time | Duration of procedure | Day 0 - Time of stop minus time of start |
| Intra-Operative Bleeding Requiring Intervention | Incidence of intervention for intra-operative staple-line bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Lee, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
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Between 21 July 2010 and 17 March 2011 patients were recruited at 2 medical clinic and one hospital; subjects with grades 2-4 hemorrhoids eligible for stapled hemorroidopexy were assessed for eligibility for study; exclusion criteria: pregnant,Ab use for SSI, drug/alcohol abuse, aspirin/anticuagulant therapy, hx VT, hx PE,
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| ID | Title | Description |
|---|---|---|
| FG000 | Covidien EEA Hemorrhoid and Prolapse Stapler | Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Covidien EEA Hemorrhoid and Prolapse Stapler | Subjects undergoing hemorrhoidopexy with HEEA stapler |
| 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 | Uneventful Creation of a Functional Staple Line at First Firing of Device | Successful creation of staple line at first firing of device during hemorrhoidopexy | Number | participants | about 20 minutes for procedure |
|
|
Adverse events were colllected from time of enrollment (Day 0, time of surgery) until subject's final visit at one month +/- 1 week post surgery.
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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 | Covidien EEA Hemorrhoid and Prolapse Stapler | Subjects undergoing hemorrhoidopexy with HEEA stapler |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorectal Discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tam LaFleur | Covidien | 203-821-4744 | tam.lafleur@covidien.com |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Day 0 - time of surgery |
| Length of Stay | length of time between time of admission and time of discharge | Day 0, time of discharge minus time of admission |
| Time to Return to Normal Activity | 30 days post op |
| Incidence of Stapler Malfunction or Misfires | about 20 minutes for procedure |
| Post Operative Pain | Post operative pain measured by 11 point visual analog scale, measured as change from baseline The scale range is 0-10, where 0 = no pain and 10 = worst possible pain | baseline, 30 days post op |
| Quality of Life, Physical Component | Physical component score SF36 scale measured as change from baseline the scoring ranges from 0 to 100 with 0 = unable to do anything while 100 = capable of physical activity without limitation | baseline, 30 days post op |
| Quality of Life, Mental Component | quality of life, SF36 measure as change from baseline the scoring ranges from 0 to 100 with 0 = complete mental activity limitation; while 100 = capable of mental activity without limitation | Baseline, 30 days post op |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | OR Time | Duration of procedure | Mean | Standard Deviation | minutes | Day 0 - Time of stop minus time of start |
|
|
|
| Secondary | Intra-Operative Bleeding Requiring Intervention | Incidence of intervention for intra-operative staple-line bleeding | Number | participants | Day 0 - time of surgery |
|
|
|
| Secondary | Length of Stay | length of time between time of admission and time of discharge | Mean | Standard Deviation | Minutes | Day 0, time of discharge minus time of admission |
|
|
|
| Secondary | Time to Return to Normal Activity | Mean | Standard Deviation | Days | 30 days post op |
|
|
|
| Secondary | Incidence of Stapler Malfunction or Misfires | Number | participants | about 20 minutes for procedure |
|
|
|
| Secondary | Post Operative Pain | Post operative pain measured by 11 point visual analog scale, measured as change from baseline The scale range is 0-10, where 0 = no pain and 10 = worst possible pain | Mean | Standard Deviation | units on a scale | baseline, 30 days post op |
|
|
|
| Secondary | Quality of Life, Physical Component | Physical component score SF36 scale measured as change from baseline the scoring ranges from 0 to 100 with 0 = unable to do anything while 100 = capable of physical activity without limitation | Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire. | Mean | Standard Deviation | units on a scale | baseline, 30 days post op |
|
|
|
| Secondary | Quality of Life, Mental Component | quality of life, SF36 measure as change from baseline the scoring ranges from 0 to 100 with 0 = complete mental activity limitation; while 100 = capable of mental activity without limitation | Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire. | Mean | Standard Deviation | units on a scale | Baseline, 30 days post op |
|
|
|
| 0 |
| 27 |
| 15 |
| 27 |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| proctalgia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rectal Hemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| vomitting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Local Swelling | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Post procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |