Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy
This study is currently recruiting participants.
Verified September 2012 by Asan Medical Center
Sponsor:
Asan Medical Center
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
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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 May 19, 2013