- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01683877
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
Conditions
Intervention / Treatment
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
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Seoul, Korea, Republic of, 138-736
- Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
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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)
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After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
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Active Comparator: Electrocautery group
After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery
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After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hemostasis time
Time Frame: Immediately after operation
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Immediately after operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ovarian function after surgery
Time Frame: within 6 months after surgery
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within 6 months after surgery
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Operative time
Time Frame: 1 day (Immediately after surgery)
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1 day (Immediately after surgery)
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Intraoperative blood loss
Time Frame: During surgery
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During surgery
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Postoperative drainage duration
Time Frame: within 1 week after surgery
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within 1 week after surgery
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Length of postoperative stay
Time Frame: within 1 month after surgery
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within 1 month after surgery
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Postoperative complications
Time Frame: within 1 months after surgery
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Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0.
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within 1 months after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
Other Study ID Numbers
- FloSeal-OC
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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