Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

Study Overview
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Brief Summary
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To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy

Official Title
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PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY

Conditions
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Benign Ovarian Tumor

Intervention / Treatment
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* Procedure: FloSeal application
* Procedure: Electrocautery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FloSeal group<br>After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy) | Procedure: FloSeal application<br>* After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)<br>|
| Active Comparator: Electrocautery group<br>After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery | Procedure: Electrocautery<br>* After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis time |  | Immediately after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian function after surgery |  | within 6 months after surgery | 
| Operative time |  | 1 day (Immediately after surgery) | 
| Intraoperative blood loss |  | During surgery | 
| Postoperative drainage duration |  | within 1 week after surgery | 
| Length of postoperative stay |  | within 1 month after surgery | 
| Postoperative complications | Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0. | within 1 months after surgery |