Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

NCT01683877 | Completed

• 1 other identifier: FloSeal-OC
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Hemostasis time

  Immediately after operation

Secondary Outcomes (6)

• Ovarian function after surgery

  within 6 months after surgery

• Operative time

  1 day (Immediately after surgery)

• Intraoperative blood loss

  During surgery

• Postoperative drainage duration

  within 1 week after surgery

• Length of postoperative stay

  within 1 month after surgery

Study Arms (2)

FloSeal group

EXPERIMENTAL

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

Procedure: FloSeal application

Electrocautery group

ACTIVE COMPARATOR

After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

Procedure: Electrocautery

Interventions

FloSeal application PROCEDURE

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

FloSeal group

Electrocautery PROCEDURE

After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

Electrocautery group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

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

Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

Electrocoagulation

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Joo-Hyun Nam, M.D., Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2012
• First Posted: September 12, 2012
• Study Start: June 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

KR (1)