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Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

Primary Purpose

Benign Ovarian Tumor

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FloSeal application
Electrocautery
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Ovarian Tumor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FloSeal group

Electrocautery group

Arm Description

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 electrocautery

Outcomes

Primary Outcome Measures

Hemostasis time

Secondary Outcome Measures

Ovarian function after surgery
Operative time
Intraoperative blood loss
Postoperative drainage duration
Length of postoperative stay
Postoperative complications
Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0.

Full Information

First Posted
September 3, 2012
Last Updated
September 29, 2023
Sponsor
Asan Medical Center
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01683877
Brief Title
Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy
Official Title
PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Ovarian Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FloSeal group
Arm Type
Experimental
Arm Description
After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
Arm Title
Electrocautery group
Arm Type
Active Comparator
Arm Description
After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery
Intervention Type
Procedure
Intervention Name(s)
FloSeal application
Intervention Description
After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
Intervention Type
Procedure
Intervention Name(s)
Electrocautery
Intervention Description
After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery
Primary Outcome Measure Information:
Title
Hemostasis time
Time Frame
Immediately after operation
Secondary Outcome Measure Information:
Title
Ovarian function after surgery
Time Frame
within 6 months after surgery
Title
Operative time
Time Frame
1 day (Immediately after surgery)
Title
Intraoperative blood loss
Time Frame
During surgery
Title
Postoperative drainage duration
Time Frame
within 1 week after surgery
Title
Length of postoperative stay
Time Frame
within 1 month after surgery
Title
Postoperative complications
Description
Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0.
Time Frame
within 1 months after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Hyun Nam, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

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