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

Not Applicable

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Device: LIGASURE; Other: Standard Surgical resection

• Registration Number: NCT01549925
• Lead Sponsor: University of Utah

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-10-02
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-21
• Last Update Submitted: 2015-12-21
• Results First Posted: 2016-01-28
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIGASURE	LIGASURE	Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
standard surgical resection	Standard Surgical resection	standard surgical resection using clamps and surgical ligatures

Primary Outcome Measures

Name	Time	Method
Surgical Time	at time of surgery, up to 10 minutes	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

Trial Locations

Locations (2)

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

Intermountain Health Care; 🇺🇸 Salt Lake City, Utah, United States