Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

Asan Medical Center

Status

Completed

Conditions

Benign Ovarian Tumor

Treatments

Procedure: FloSeal application

Procedure: Electrocautery

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01683877

FloSeal-OC

Details and patient eligibility

About

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

Enrollment

128 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

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