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The objective of this prospective randomized surgical trial is to evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures.
This research study is a prospective, randomized trial. Women who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants. Only patients with documented ovarian cancer by histologic examination at the time of the cytoreductive or staging surgery, and that are also undergoing omentectomy and/or recto-sigmoid colon resection will be eligible for participation. Patients who are eligible for participation and who are willing to participate will be randomized during the surgical procedure to standard surgical resection using clamps and surgical ligatures versus resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon. The resection of these tissues will be performed as part of the usual surgical protocol for women with ovarian cancer and will not be done so unless the tissues are the sites of metastatic disease or if their removal would be performed for staging purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard surgical resection | Other | standard surgical resection using clamps and surgical ligatures |
|
| LIGASURE | Active Comparator | Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Surgical resection | Other | standard surgical resection using clamps and surgical ligatures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Time | To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures | at time of surgery, up to 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Health Care | Salt Lake City | Utah | 84111 | United States | ||
| Huntsman Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Surgical Resection | standard surgical resection using clamps and surgical ligatures Standard Surgical resection: standard surgical resection using clamps and surgical ligatures |
| FG001 | LIGASURE | Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Surgical Resection | standard surgical resection using clamps and surgical ligatures Standard Surgical resection: standard surgical resection using clamps and surgical ligatures |
| BG001 | LIGASURE |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Surgical Time | To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures | Posted | Mean | 95% Confidence Interval | SECONDS | at time of surgery, up to 10 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 | Standard Surgical Resection | standard surgical resection using clamps and surgical ligatures Standard Surgical resection: standard surgical resection using clamps and surgical ligatures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Wade | Huntsman Cancer Institute | 801-213-5746 | mark.wade@hci.utah.edu |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| LIGASURE | Device | resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon |
|
| Salt Lake City |
| Utah |
| 84112 |
| United States |
Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | LIGASURE | Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon | 0 | 25 | 0 | 25 |
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| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |