Benign Ovarian Tumor
Conditions
Brief summary
To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy
Interventions
PROCEDUREFloSeal application
After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
PROCEDUREElectrocautery
After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery
Sponsors
Baxter Healthcare Corporation
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Premenopausal women * Patients who is planned to undergo laparoscopic ovarian cystectomy * American Society of Anesthesiologists Physical Status classification (ASA PS) 1-2 * Patients with adequate bone marrow, renal and hepatic function: WBC \> 3,000 cells/mcl Platelets \>100,000/mcl Creatinine \<2.0 mg/dL Bilirubin \<1.5 x normal and SGOT or SGPT \<3 x normal * Patient must be suitable candidates for surgery * Patients who have signed an approved Informed Consent
Exclusion criteria
* Patients with a history of pelvic or abdominal radiotherapy; * Patients who are pregnant or nursing * Patients who is receiving or requires hormone replacement therapy after surgery * Patients who is undergoing hysterectomy at this time * Patients who is undergoing unilateral or bilateral oophorectomy * Previous history of ovarian cystectomy or oophorectomy * Patients with contraindications to surgery * Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * Patient compliance and geographic proximity that do not allow adequate follow-up. * Hormone therapy within 3 months before surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostasis time | Immediately after operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | 1 day (Immediately after surgery) | — |
| Intraoperative blood loss | During surgery | — |
| Ovarian function after surgery | within 6 months after surgery | — |
| Length of postoperative stay | within 1 month after surgery | — |
| Postoperative complications | within 1 months after surgery | Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0. |
| Postoperative drainage duration | within 1 week after surgery | — |
Countries
South Korea
Outcome results
None listed