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

Epithelial Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549925
• Other study ID #: HCI41380
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: December 21, 2015
• Start date: January 2011
• Est. completion date: September 2014

Study information

• Verified date: December 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Standard Surgical resection
standard surgical resection using clamps and surgical ligatures

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

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Intermountain Health Care	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	at time of surgery, up to 10 minutes	No