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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01549925
First received: March 6, 2012
Last updated: September 30, 2013
Last verified: September 2013

March 6, 2012
September 30, 2013
January 2011
September 2013   (final data collection date for primary outcome measure)
Surgical time [ Time Frame: At time of Surgery ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01549925 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand
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

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.

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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epithelial Ovarian Cancer
  • 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
  • standard surgical resection
    standard surgical resection using clamps and surgical ligatures
    Intervention: Other: Standard Surgical resection
  • Active Comparator: LIGASURE
    Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
    Intervention: Device: LIGASURE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01549925
HCI41380
Yes
University of Utah
University of Utah
Not Provided
Not Provided
University of Utah
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP