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
  Purpose

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.


Condition Intervention
Epithelial Ovarian Cancer
Other: Standard Surgical resection
Device: LIGASURE

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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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


Enrollment: 50
Study Start Date: January 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
standard surgical resection
standard surgical resection using clamps and surgical ligatures
Other: Standard Surgical resection
standard surgical resection using clamps and surgical ligatures
Active Comparator: LIGASURE
Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
Device: LIGASURE
resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549925

Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Intermountain Health Care
Salt Lake City, Utah, United States, 84111
Sponsors and Collaborators
University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01549925     History of Changes
Other Study ID Numbers: HCI41380
Study First Received: March 6, 2012
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 28, 2014