Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Epithelial Ovarian Cancer

Treatments: Other: Standard Surgical resection; Device: LIGASURE

Study type: Interventional

Funder types: Other

Identifiers

NCT01549925

HCI41380

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

standard surgical resection

Other group

Description:

standard surgical resection using clamps and surgical ligatures

Treatment:

Other: Standard Surgical resection

LIGASURE

Active Comparator group

Description:

Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

Treatment:

Device: LIGASURE