Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy
Conditions
Benign Ovarian Tumor
Conditions: official terms
Ovarian Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: FloSeal application Type: Procedure
Name: Electrocautery Type: Procedure
Overall Status
Recruiting
Summary
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
Location
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
Sponsors
Asan Medical Center
Source
Asan Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page