Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

Not Applicable

Completed

• Conditions: Benign Ovarian Tumor
• Interventions: Procedure: FloSeal application; Procedure: Electrocautery

• Registration Number: NCT01683877
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-08
• Study First Posted: 2012-09-12
• Study Start: 2013-06
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FloSeal group	FloSeal application	After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
Electrocautery group	Electrocautery	After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

Primary Outcome Measures

Name	Time	Method
Hemostasis time	Immediately after operation

Secondary Outcome Measures

Name	Time	Method
Intraoperative blood loss	During surgery
Operative time	1 day (Immediately after surgery)
Postoperative drainage duration	within 1 week after surgery
Ovarian function after surgery	within 6 months after surgery
Length of postoperative stay	within 1 month after surgery
Postoperative complications	within 1 months after surgery	Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of