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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01549925 |
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Date of registration:
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06/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand
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Scientific title:
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A Prospective Randomized Surgical Trial Comparing the Efficacy of LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Standard Surgical Resection in Women With Stage IIIC or Stage IVA Epithelial Ovarian Cancer |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01549925 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients must be 18 years or older
- All patients who are suspected to have an early or late stage ovarian cancer during
their preoperative evaluation will be potential study participants.
- Potential candidates must have signed an IRB-approved Informed Consent (University of
Utah Informed consent if their surgery will be performed at the Huntsman Cancer
Hospital, or Intermountain Health Care consent if the surgery is to be performed at
LDSH or IMC.
- 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.
Exclusion Criteria:
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Epithelial Ovarian Cancer
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Intervention(s)
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Other: Standard Surgical resection
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Device: LIGASURE
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Primary Outcome(s)
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Surgical Time
[Time Frame: at time of surgery, up to 10 minutes]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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