Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

NCT ID: NCT01683877

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2017-12-31

Brief Summary

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

Conditions

Benign Ovarian Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FloSeal group

After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)

Group Type: EXPERIMENTAL

FloSeal application

Intervention Type: PROCEDURE

After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)

Electrocautery group

After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

Group Type: ACTIVE_COMPARATOR

Electrocautery

Intervention Type: PROCEDURE

After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

Interventions

FloSeal application

After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)

Intervention Type: PROCEDURE

Electrocautery

After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joo-Hyun Nam

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joo-Hyun Nam, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

FloSeal-OC

Identifier Type: -

Identifier Source: org_study_id