Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

This study is currently recruiting participants.
Verified September 2012 by Asan Medical Center
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Joo-Hyun Nam, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01683877
First received: September 3, 2012
Last updated: September 16, 2012
Last verified: September 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Asan Medical Center:

Primary Outcome Measures:
  • Hemostasis time [ Time Frame: Immediately after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ovarian function after surgery [ Time Frame: within 6 months after surgery ] [ Designated as safety issue: No ]
  • Operative time [ Time Frame: 1 day (Immediately after surgery) ] [ Designated as safety issue: No ]
  • Intraoperative blood loss [ Time Frame: During surgery ] [ Designated as safety issue: No ]
  • Postoperative drainage volume [ Time Frame: within 2 days after surgery ] [ Designated as safety issue: No ]
  • Postoperative drainage duration [ Time Frame: within 1 week after surgery ] [ Designated as safety issue: No ]
  • Length of postoperative stay [ Time Frame: within 1 month after surgery ] [ Designated as safety issue: No ]
  • Postoperative complications [ Time Frame: within 1 months after surgery ] [ Designated as safety issue: Yes ]
    Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0.


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   20 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683877

Contacts
Contact: Joo-Hyun Nam, M.D., Ph.D. 82-2-3010-3633 jhnam@amc.seoul.kr

Locations
Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joo-Hyun Nam, M.D., Ph.D.    82-2-3010-3633    jhnam@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Baxter Healthcare Corporation
Investigators
Principal Investigator: Joo-Hyun Nam, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Joo-Hyun Nam, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01683877     History of Changes
Other Study ID Numbers: FloSeal-OC
Study First Received: September 3, 2012
Last Updated: September 16, 2012
Health Authority: Korea: Asan Medical Center Institutional Review Board

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014