Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

September 29, 2023 updated by: Joo-Hyun Nam, Asan Medical Center

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

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

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 138-736
        • Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FloSeal group
After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
Active Comparator: Electrocautery group
After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery
After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemostasis time
Time Frame: Immediately after operation
Immediately after operation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joo-Hyun Nam, M.D., Ph.D., Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 3, 2012

First Submitted That Met QC Criteria

September 8, 2012

First Posted (Estimated)

September 12, 2012

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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