Benign Ovarian CystPRAHA-2NCT04643106
Comparison of Hemostatic Agent to Suture in Terms of Hemostatic Function and Preservation of Ovarian Function
A study testing Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy and suturing with barbed sutures during laparoscopic ovarian cystectomy in people with Benign Ovarian Cyst, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
This study aims to evaluate the efficacy of preservation of ovarian function, hemostasis, and safety of a hemostatic agent versus suturing during laparoscopic ovarian cystectomy for ovarian endometriosis. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Benign Ovarian Cyst
- What is being tested?
- Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy and suturing with barbed sutures during laparoscopic ovarian cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 25 Feb 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent.
- Age: 19-45 year-old women
- American Society of Anesthesiologists Physical Status classification 1 or 2
- Plan of laparoscopic ovarian cystectomy for unilateral or bilateral ovarian endometriosis diagnosed by ultrasonography
- Regular menstruation every 21-45 days
Who cannot join
- No 'ovarian' endometriosis
- Suspicious disease of ovarian malignancy
- Age: 18 and younger, 46 and older
- Pregnancy or breastfeeding.
- Lower than 0.05 ng/ml of serum Anti-mullerian hormone level
- Hormonal therapy within recent 3 months
- Considered as inappropriate by the researcher's judgment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Not yet recruiting
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326
Ga Won Yim, MD/PhD, 82-31-961-7366, gawonyim@gmail.com
Chae Hyeong Lee, MD/PhD
- Recruiting
Seoul National University Hospital
Seoul
Hyunji Lim, MD, 82-2-2072-2643, hyunji3292@gmail.com
Hee Seung Kim, MD/PhD, 82-2-2072-4863, bboddi0311@gmail.com
About this study
Official title: A Multi-center, Randomized, Investigator-initiated Trial to Evaluate the Efficacy of PRreservation of ovArian Function, Hemostasis, and sAfety of a Hemostatic Agent Versus Suturing During Laparoscopic Ovarian Cystectomy for Endometrioma
This study aims to evaluate the efficacy of preservation of ovarian function, hemostasis, and safety of a hemostatic agent versus suturing during laparoscopic ovarian cystectomy for ovarian endometriosis.
Read the detailed description
In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function.
Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.
- Conditions
- Benign Ovarian Cyst
- Being tested
- Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy, suturing with barbed sutures during laparoscopic ovarian cystectomy
- Keywords
- endometriosis, endometrioma, ovarian cystectomy, ovarian function, ovarian reserve, hemostatic agent, suture
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomyProcedure or surgery
During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)
suturing with barbed sutures during laparoscopic ovarian cystectomyProcedure or surgery
During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding
| Study group | Role | What they receive |
|---|---|---|
| Hemostatic agent group | Experimental | During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL® Fibrin Sealant, Ethicon, USA), which consist of thrombin and coagulating proteins, mainly fibrinogen and fibronectin. If hemostasis is not fulfilled enough by using it, a additional intervention such as electrocoagulation with bipolar forceps and barbed suture is required to stop bleeding. Receives: Procedure: Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy |
| Suturing group | Active comparator | During operation, barbed suture will be applied to the inner surface of ovarian parenchyme where ovarian endometriosis was attached. In this group, if bleeding is continued after suturing, additional electrocoagulation with bipolar forceps will be conducted. Receives: Procedure: suturing with barbed sutures during laparoscopic ovarian cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian function preservation 12 weeks after surgery
Reduction rate of AMH level in serum 12 weeks after surgery
Measured: 12 weeks after surgery
Secondary outcomes (9)
Ovarian function preservation 48 weeks after surgery
Reduction rate of AMH level in serum 48 weeks after surgery
Measured: 48 weeks after surgery
The time required to finish hemostasis
Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated how long the time have been spent for bleeding control
Measured: during operation
the success rate of hemostasis within 10 minutes
Stop-watch will be operated right after finishing stripping endometrioma. It will be evaluated whether hemostasis is finished within 10 minutes
Measured: during operation
Blood loss during operation
The volume of blood loss will be estimated by using simple visual assessment technique referring to gauze count and irrigation bottle
Measured: during operation
Hemoglobin
Change of serum hemoglobin from baseline
Measured: post-op 2 days, 12 weeks and 48 weeks
Transfusion during admission
whether patients are transfused during admission period
Measured: post-op 2 days
Adverse events associated with operation, bleeding or transfusion
any adverse events during admission period
Measured: post-op 2 days
Hospitalization period
days from admission day to discharge day
Measured: within post-op 2 weeks
Operation running time
time from anesthesia start to delivery of patient to recovery room
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start25 Feb 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Ovarian CystStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Seung Kim, Seoul National University Hospital
- Investigators
- Hee seung Kim, MD/PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643106
- Sponsor's protocol ID
- 2008-059-1147
- Acronym
- PRAHA-2
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 2020
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim H, Park SJ, Paik H, Mun J, Lee EJ, Lee S, Lim W, Song G, Shim SH, Lee CH, Yim GW, Kim HS; PRAHA Study Group. Preservation of the ovarian reserve and hemostasis during laparoscopic ovarian cystectomy by a hemostatic agent versus suturing for patients with ovarian endometriosis: study protocol for randomized controlled, non-inferiority trial (PRAHA-2 trial). Trials. 2021 Jul 21;22(1):473. doi: 10.1186/s13063-021-05431-1.
PubMed 34289889
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Investigator-initiated Trial to Evaluate the Efficacy of PRreservation of ovArian Function, Hemostasis, and sAfety of a Hemostatic Agent Versus Suturing During Laparoscopic Ovarian Cystectomy for Endometrioma
- ClinicalTrials.gov ID
- NCT04643106
- Acronym / sponsor ID
- PRAHA-2 / 2008-059-1147
- Conditions
- Benign Ovarian Cyst
- Keywords
- endometriosis, endometrioma, ovarian cystectomy, ovarian function, ovarian reserve, hemostatic agent, suture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Nov 2020 (actual)
- 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.
This study aims to evaluate the efficacy of preservation of ovarian function, hemostasis, and safety of a hemostatic agent versus suturing during laparoscopic ovarian cystectomy for ovarian endometriosis.
Detailed description
In women with endometrioma who plan to undergo laparoscopic ovarian cystectomy, surgical technique can influence postoperative ovarian function because of removal of normal ovarian tissue with ovarian cyst and damage to ovarian tissue during bleeding control after stripping of endometrioma. This study is designed to compare hemostatic sealant to suturing in terms of hemostatic function, safety and preservation of ovarian function.
Ovarian function of all patients will be evaluated on pre op, post op 12 weeks, post op 48 weeks by measuring AMH and ovarian volume. And Hemostatic function will be evaluated by measuring serum hemoglobin, blood loss during operation, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemostatic agent group | Experimental | Procedure: Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomyDuring laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL® Fibrin Sealant, Ethicon, USA), which consist of thrombin and coagulating proteins, mainly fibrinogen and fibronectin. If hemostasis is not fulfilled enough by using it, a additional intervention such as electrocoagulation with bipolar forceps and barbed suture is required to stop bleeding. |
| Suturing group | Active comparator | Procedure: suturing with barbed sutures during laparoscopic ovarian cystectomyDuring operation, barbed suture will be applied to the inner surface of ovarian parenchyme where ovarian endometriosis was attached. In this group, if bleeding is continued after suturing, additional electrocoagulation with bipolar forceps will be conducted. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed consent.
- Age: 19-45 year-old women
- American Society of Anesthesiologists Physical Status classification 1 or 2
- Plan of laparoscopic ovarian cystectomy for unilateral or bilateral ovarian endometriosis diagnosed by ultrasonography
- Regular menstruation every 21-45 days
Key exclusion criteria (7 listed)
- No 'ovarian' endometriosis
- Suspicious disease of ovarian malignancy
- Age: 18 and younger, 46 and older
- Pregnancy or breastfeeding.
- Lower than 0.05 ng/ml of serum Anti-mullerian hormone level
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 |
|---|---|---|
| Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomyDuring laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®) | Procedure or surgery | Hemostatic agent group |
| suturing with barbed sutures during laparoscopic ovarian cystectomyDuring laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding | Procedure or surgery | Suturing group |
Primary outcome
Ovarian function preservation 12 weeks after surgery
Time frame: 12 weeks after surgery
Reduction rate of AMH level in serum 12 weeks after surgery
9 secondary outcomes
Ovarian function preservation 48 weeks after surgery
Time frame: 48 weeks after surgery
The time required to finish hemostasis
Time frame: during operation
the success rate of hemostasis within 10 minutes
Time frame: during operation
Blood loss during operation
Time frame: during operation
Hemoglobin
Time frame: post-op 2 days, 12 weeks and 48 weeks
Transfusion during admission
Time frame: post-op 2 days
Adverse events associated with operation, bleeding or transfusion
Time frame: post-op 2 days
Hospitalization period
Time frame: within post-op 2 weeks
Operation running time
Time frame: during operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Derived from this study: PubMed 34289889Lim H, Park SJ, Paik H, Mun J, Lee EJ, Lee S, Lim W, Song G, Shim SH, Lee CH, Yim GW, Kim HS; PRAHA Study Group. Preservation of the ovarian reserve and hemostasis during laparoscopic ovarian cystectomy by a hemostatic agent versus suturing for patients with ovarian endometriosis: study protocol for randomized controlled, non-inferiority trial (PRAHA-2 trial). Trials. 2021 Jul 21;22(1):473. doi: 10.1186/s13063-021-05431-1.
- Individual participant dataSharing planned: No
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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.
Hee seung Kim, MD/PhD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy and suturing with barbed sutures during laparoscopic ovarian cystectomy in people with Benign Ovarian Cyst, run by Seoul National University Hospital at 2 sites 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyunji Lim, MD (82-2-2072-2821, hyunji3292@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian function preservation 12 weeks after surgery (time frame: 12 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04643106, which also lists 1 linked publication.
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 26 Jun 2023.