Benign Ovarian TumorNCT01683877
Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy
A study testing FloSeal application and Electrocautery in people with Benign Ovarian Tumor, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Benign Ovarian Tumor
- What is being tested?
- FloSeal application and Electrocautery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
About this study
Official title: 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
- Conditions
- Benign Ovarian Tumor
- Being tested
- FloSeal application, Electrocautery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloSeal applicationProcedure or surgery
After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
ElectrocauteryProcedure or surgery
After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery
| Study group | Role | What they receive |
|---|---|---|
| FloSeal group | Experimental | After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy) Receives: Procedure: FloSeal application |
| Electrocautery group | Active comparator | After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery Receives: Procedure: Electrocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis time
Measured: Immediately after operation
Secondary outcomes (6)
Ovarian function after surgery
Measured: within 6 months after surgery
Operative time
Measured: 1 day (Immediately after surgery)
Intraoperative blood loss
Measured: During surgery
Postoperative drainage duration
Measured: within 1 week after surgery
Length of postoperative stay
Measured: within 1 month after surgery
Postoperative complications
Postoperative complications will be evaluated with Dindo's classification for postoperative complication and CTCAE v4.0.
Measured: within 1 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startJun 2013
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Ovarian TumorStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Joo-Hyun Nam, Asan Medical Center
- Investigators
- Joo-Hyun Nam, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683877
- Sponsor's protocol ID
- FloSeal-OC
- Status last verified
- Sep 2023
- First submitted
- 3 Sep 2012
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY
- ClinicalTrials.gov ID
- NCT01683877
- Acronym / sponsor ID
- FloSeal-OC
- Conditions
- Benign Ovarian Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FloSeal group | Experimental | Procedure: FloSeal applicationAfter laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy) |
| Electrocautery group | Active comparator | Procedure: ElectrocauteryAfter laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FloSeal applicationAfter laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy) | Procedure or surgery | FloSeal group |
| ElectrocauteryAfter laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery | Procedure or surgery | Electrocautery group |
Primary outcome
Hemostasis time
Time frame: Immediately after operation
6 secondary outcomes
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo-Hyun Nam, M.D., Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FloSeal application and Electrocautery in people with Benign Ovarian Tumor, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostasis time (time frame: Immediately after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.