N/A
N=50
Surgical Trial Comparing LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Stand
Epithelial Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01549925 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Surgical Time — 417; 338 SECONDS
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Surgical resection (Other); LIGASURE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Utah
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Time |
417; 338 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01549925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.