Epithelial Ovarian Cancer
Conditions
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.
Interventions
standard surgical resection using clamps and surgical ligatures
DEVICELIGASURE
resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Surgical Resection standard surgical resection using clamps and surgical ligatures
Standard Surgical resection: standard surgical resection using clamps and surgical ligatures | 25 |
| LIGASURE Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Standard Surgical Resection | LIGASURE | Total |
|---|---|---|---|
| Age, Customized 50-70 years | 16 Participants | 13 Participants | 29 Participants |
| Age, Customized < 50 years | 1 Participants | 7 Participants | 8 Participants |
| Age, Customized >70 years | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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
Time frame: at time of surgery, up to 10 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Surgical Resection | Surgical Time | 417 SECONDS |
| LIGASURE | Surgical Time | 338 SECONDS |