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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
No
United States: Institutional Review Board
HCI41380
NCT01549925
January 2011
December 2013
Name | Location |
---|---|
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Intermountain Health Care | Salt Lake City, Utah 84103 |