Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy
Benign Ovarian Tumor
Conditions: official terms
Ovarian Neoplasms
Study Type
Study Phase
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Name: FloSeal application Type: Procedure
Name: Electrocautery Type: Procedure
Overall Status
To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Female
Criteria: 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
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Joo-Hyun Nam, M.D., Ph.D. - 82-2-3010-3633 - jhnam@amc.seoul.kr
Start Date
September 2012
Asan Medical Center
Asan Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page