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Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01683877
First Posted: September 12, 2012
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center
  Purpose
To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy

Condition Intervention
Benign Ovarian Tumor Procedure: FloSeal application Procedure: Electrocautery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY

Resource links provided by NLM:


Further study details as provided by Joo-Hyun Nam, Asan Medical Center:

Primary Outcome Measures:
  • Hemostasis time [ Time Frame: Immediately after operation ]

Secondary Outcome Measures:
  • Ovarian function after surgery [ Time Frame: within 6 months after surgery ]
  • Operative time [ Time Frame: 1 day (Immediately after surgery) ]
  • Intraoperative blood loss [ Time Frame: During surgery ]
  • Postoperative drainage volume [ Time Frame: within 2 days after surgery ]
  • Postoperative drainage duration [ Time Frame: within 1 week after surgery ]
  • Length of postoperative stay [ Time Frame: 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.


Estimated Enrollment: 130
Study Start Date: September 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FloSeal group
After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
Procedure: FloSeal application
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
Procedure: Electrocautery
After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

  Eligibility

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683877


Locations
Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Baxter Healthcare Corporation
Investigators
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
  More Information

Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01683877     History of Changes
Other Study ID Numbers: FloSeal-OC
First Submitted: September 3, 2012
First Posted: September 12, 2012
Last Update Posted: May 31, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Hemostatics
Coagulants