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The purpose of this study is to find out how much a trocar might slide during a typical laparoscopic hysterectomy. We also want to find out if there is a difference between how much three commonly used trocars slide and if a device called LaproStop has an effect on the slippage.
Patients will be randomly assigned into the different trocar groups. After this assignment has been made, we will then assign the Laprostop to one of the two trocars by chance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ethicon Xcel Trocars | Active Comparator | Ethicon Xcel trocars will be used in this arm with Laprostop device |
|
| Covidien Veraport Trocars | Active Comparator | Covidien Veraport Trocars will be used in this arm with the Laprostop device |
|
| Storz Reusable Trocars | Active Comparator | Storz Reusable Trocars will be used in this arm with the Laprostop device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LaproStop | Device | One of the subject's trocars will be randomized to be used with a LaproStop device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trocar Slippages With LaproStop | Number of participants with slippages with LaproStop | During the hysterectomy procedure, up to 2 hours and 32 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Trocar Slippages Without LaproStop | Number of participants with slippages with LaproStop | During the hysterectomy procedure, up to 2 hours and 32 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon I Einarsson, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minimal Invasieve Gynaecology Surgery, Brigham and Women's Hospital | Boston | Massachusetts | 02215 | United States |
All enrolled participants were included in the trial
Recruitment took place in a tertiary hospital, from 12-26-12 to 06-18-13
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| ID | Title | Description |
|---|---|---|
| FG000 | Covidien Veraport Trocars | LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. |
| FG001 | Ethicon Xcel Trocars | LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. |
| FG002 | Storz Reusable Trocars | LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Covidien Veraport Trocars | LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. |
| BG001 | Ethicon Xcel Trocars | LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. |
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Trocar Slippages Without LaproStop | Number of participants with slippages with LaproStop | Posted | Number | Participants | During the hysterectomy procedure, up to 2 hours and 32 minutes |
|
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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 Veraport Trocars | LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. |
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There were no adverse events encountered during this study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. JI Einarsson | BWH | 617-525-8582 | jeinarsson@partners.org |
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| BG002 | Storz Reusable Trocars | LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
|
|
| Primary | Trocar Slippages With LaproStop | Number of participants with slippages with LaproStop | Pilot study | Posted | Number | Participants | During the hysterectomy procedure, up to 2 hours and 32 minutes |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Ethicon Xcel Trocars | LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. | 0 | 5 | 0 | 5 |
| EG002 | Storz Reusable Trocars | LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device. | 0 | 5 | 0 | 5 |
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