Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

Benign Ovarian Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683877
• Other study ID #: FloSeal-OC
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2017

Study information

• Verified date: September 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Ovarian Tumor
• Ovarian Neoplasms

Intervention

Procedure:
• FloSeal application
After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
• Electrocautery
After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Baxter Healthcare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis time		Immediately after operation
Secondary	Ovarian function after surgery		within 6 months after surgery
Secondary	Operative time		1 day (Immediately after surgery)
Secondary	Intraoperative blood loss		During surgery
Secondary	Postoperative drainage duration		within 1 week after surgery
Secondary	Length of postoperative stay		within 1 month after surgery
Secondary	Postoperative complications	Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0.	within 1 months after surgery