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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Epithelial Ovarian Cancer

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Trial Information

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.


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:

- none

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Surgical time

Outcome Description:

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

Outcome Time Frame:

At time of Surgery

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

HCI41380

NCT ID:

NCT01549925

Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

  • Epithelial Ovarian Cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112
Intermountain Health CareSalt Lake City, Utah  84103