Ovarian CystsNCT06913335
Comparison Between Electrosurgical Energy and Hemostatic Sealants on Hemostasis in Laparoscopic Ovarian Cystectomy
A study testing laparoscopic ovarian cystectomy using hemostatic sealant and laparoscopic ovarian cystectomy using electrosurgical energy in people with Ovarian Cysts, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this study is to compare between the effect of using electrosurgical energy and hemostatic sealant for hemostasis in laparoscopic cystectomy for ovarian cysts. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Ovarian Cysts
- What is being tested?
- laparoscopic ovarian cystectomy using hemostatic sealant and laparoscopic ovarian cystectomy using electrosurgical energy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 May 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years old.
- Women with unilateral or bilateral benign ovarian cyst provisionally diagnosed by ultrasound and normal tumor markers.
- Women fit for laparoscopic surgery
Who cannot join
- Pregnant women.
- Postmenopausal women.
- Premenarchal girls.
- Women with a history of recent pelvic or abdominal radiotherapy.
- Women with serious concurrent systemic disorders.
- Known ovarian malignancy provisionally diagnosed by ultrasound (US) or tumor markers.
- Women with coagulopathy or bleeding disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
mustafa farag ellkany, MD contact
About this study
Official title: Optimizing Hemostasis in Laparoscopic Ovarian Cystectomy: A Comparison Between Electrosurgical Energy and Hemostatic Sealants.
The aim of this study is to compare between the effect of using electrosurgical energy and hemostatic sealant for hemostasis in laparoscopic cystectomy for ovarian cysts.
Read the detailed description
Ovarian cysts are common in women during childbearing period. Most cysts are normal functional cysts that typically resolve spontaneously and need no treatment. However, pathologic cysts such as endometriomas and dermoid may require surgical intervention.( For women of childbearing age with symptomatic ovarian cysts, laparoscopic cystectomy is the first-line surgical treatment for ovarian cysts because it has many advantages, including the benefits of ovarian-sparing surgery (with continued hormonal support and preservation of future fertility) and of minimally invasive surgery (including small incisions, quick recovery, and less pain).
Laparoscopic ovarian cystectomy is the treatment of choice for benign ovarian tumors in the young, including mature cystic teratomas, endometriomas, and serous or mucinous cystadenomas. One of the greatest challenge during the surgery is stopping bleeding from the rest ovarian tissue.
Electrosurgical energy is a commonly used technique to cut off bleeding from the remaining ovarian tissue during laparoscopic ovarian cystectomy, but it can increase time of operation , increase the risk of complications, and if used excessively, it can damage the soft tissues of the ovaries, and interfere with fertility .
Electrosurgical units can be divided into two major types: monopolar and bipolar, monopolar system refers to current flow from one active electrode through the patient, who is entirely included in the circuit, and exists via dispersive electrode to the generator, but its usage can cause collateral injuries and thermal necrosis at the point of contact.
In bipolar units, both active and return electrodes are housed within the same instrument; so, the current flows only through the tissue between the two blades of the electrode and return to the generator without passing through the whole body.
Bipolar energy is safer than monopolar energy in terms of the risk of postoperative adhesions and the risk of over treatment that can lead to ovarian failure and also provide a significant postoperative resumption of the spontaneous ovulation and pregnancy.
On the other hand, other hemostatic strategies have been investigated such as hemostatic sealants, which create a seal when applied to bleeding tissues. This process causes platelets to clump together and initiates the clotting cascade, obstructing blood flow.
Other studies, including randomized controlled trials, have consistently demonstrated that hemostatic sealants are effective in stopping bleeding and reducing blood loss at many surgical sites. This empirical evidence demonstrates the potential of a hemostatic sealant as an effective alternative to electrosurgical energy, particularly in surgical situations that require strong hemostasis, such as laparoscopic ovarian cystectomy.
Ovarian reserve is defined as the size and number of the ovarian follicle pools at any given time. Alternatively, it can be defined as the total ovarian follicle pool which is equal to the quiescent (primordial) follicles plus growing follicles. This reproductive potential is determined by the quiescent primordial follicles that can develop into primary, antral, and ovulating follicles. It can be estimated by several methods and the level of serum anti-Mullerian hormone (AMH) is considered one of the best endocrine markers .
AMH is formed by the granulosa cells of active follicles (primary follicles, preantral follicles and small antral follicles) but not by quiescent primordial follicles. AMH regulates the process of follicle formation by controlling the number of primordial follicles that initiate the maturation process, thus preventing the exhaustion of the quiescent follicles.
- Conditions
- Ovarian Cysts
- Being tested
- laparoscopic ovarian cystectomy using hemostatic sealant, laparoscopic ovarian cystectomy using electrosurgical energy
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic ovarian cystectomy using hemostatic sealantProcedure or surgery
- A small incision will be made on the ovarian surface using laparoscopic scissors.
- Nontraumatic grasping forceps will be used to dissect the cyst capsule away from the soft tissue of the ovary.
- The cyst will be removed intact to avoid spillage of its contents. If rupture occurs, the peritoneal cavity will be irrigated thoroughly.
- After the removal of the cyst, the ovarian bed should be inspected for bleeding, and if there is minimal bleeding, using of electrocautery should be avoided to minimize thermal damage to the ovary.
- The hemostatic sealant as Surgicel original, Surgicel Fibrillar (ETHICON, USA) which is an absorbable hemostat (oxidized regenerated cellulose) will be applied directly to the bleeding surface 1:5sheets of hemostat will be used.
laparoscopic ovarian cystectomy using electrosurgical energyProcedure or surgery
A small incision will be made on the ovarian surface using laparoscopic scissors.
- Nontraumatic grasping forceps will be used to dissect the cyst capsule away from the soft tissue of the ovary.
- The cyst will be removed intact to avoid spillage of its contents. If rupture occurs, the peritoneal cavity will be irrigated thoroughly.
- After the removal of the cyst, the ovarian bed should be inspected for bleeding, and if there is minimal bleeding, using of electrocautery should be avoided to minimize thermal damage to the ovary In the electrosurgical energy using group the hemostasis method will be different and will be achieved using electrosurgical energy.
- After the cyst removal and cyst bed examination, any bleeding will be carefully coagulated using bipolar electrosurgical energy
- Minimal energy will be applied for short durations to reduce collateral thermal
| Study group | Role | What they receive |
|---|---|---|
| electrosurgical energy group | Active comparator | in this group electrosurgical energy will be used to control bleeding Receives: Procedure: laparoscopic ovarian cystectomy using electrosurgical energy |
| Hemostatic Sealant group | Active comparator | in this group Hemostatic Sealant will be used to control bleeding Receives: Procedure: laparoscopic ovarian cystectomy using hemostatic sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study will be the hemostasis time
The primary outcome of this study will be the hemostasis time
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Apr 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CystsStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Yasser Fawzy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913335
- Sponsor's protocol ID
- KFSIRB200-504
- Status last verified
- Apr 2025
- First submitted
- 23 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Hemostasis in Laparoscopic Ovarian Cystectomy: A Comparison Between Electrosurgical Energy and Hemostatic Sealants.
- ClinicalTrials.gov ID
- NCT06913335
- Acronym / sponsor ID
- KFSIRB200-504
- Conditions
- Ovarian Cysts
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 6 Apr 2025 (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.
The aim of this study is to compare between the effect of using electrosurgical energy and hemostatic sealant for hemostasis in laparoscopic cystectomy for ovarian cysts.
Detailed description
Ovarian cysts are common in women during childbearing period. Most cysts are normal functional cysts that typically resolve spontaneously and need no treatment. However, pathologic cysts such as endometriomas and dermoid may require surgical intervention.( For women of childbearing age with symptomatic ovarian cysts, laparoscopic cystectomy is the first-line surgical treatment for ovarian cysts because it has many advantages, including the benefits of ovarian-sparing surgery (with continued hormonal support and preservation of future fertility) and of minimally invasive surgery (including small incisions, quick recovery, and less pain).
Laparoscopic ovarian cystectomy is the treatment of choice for benign ovarian tumors in the young, including mature cystic teratomas, endometriomas, and serous or mucinous cystadenomas. One of the greatest challenge during the surgery is stopping bleeding from the rest ovarian tissue.
Electrosurgical energy is a commonly used technique to cut off bleeding from the remaining ovarian tissue during laparoscopic ovarian cystectomy, but it can increase time of operation , increase the risk of complications, and if used excessively, it can damage the soft tissues of the ovaries, and interfere with fertility .
Electrosurgical units can be divided into two major types: monopolar and bipolar, monopolar system refers to current flow from one active electrode through the patient, who is entirely included in the circuit, and exists via dispersive electrode to the generator, but its usage can cause collateral injuries and thermal necrosis at the point of contact.
In bipolar units, both active and return electrodes are housed within the same instrument; so, the current flows only through the tissue between the two blades of the electrode and return to the generator without passing through the whole body.
Bipolar energy is safer than monopolar energy in terms of the risk of postoperative adhesions and the risk of over treatment that can lead to ovarian failure and also provide a significant postoperative resumption of the spontaneous ovulation and pregnancy.
On the other hand, other hemostatic strategies have been investigated such as hemostatic sealants, which create a seal when applied to bleeding tissues. This process causes platelets to clump together and initiates the clotting cascade, obstructing blood flow.
Other studies, including randomized controlled trials, have consistently demonstrated that hemostatic sealants are effective in stopping bleeding and reducing blood loss at many surgical sites. This empirical evidence demonstrates the potential of a hemostatic sealant as an effective alternative to electrosurgical energy, particularly in surgical situations that require strong hemostasis, such as laparoscopic ovarian cystectomy.
Ovarian reserve is defined as the size and number of the ovarian follicle pools at any given time. Alternatively, it can be defined as the total ovarian follicle pool which is equal to the quiescent (primordial) follicles plus growing follicles. This reproductive potential is determined by the quiescent primordial follicles that can develop into primary, antral, and ovulating follicles. It can be estimated by several methods and the level of serum anti-Mullerian hormone (AMH) is considered one of the best endocrine markers .
AMH is formed by the granulosa cells of active follicles (primary follicles, preantral follicles and small antral follicles) but not by quiescent primordial follicles. AMH regulates the process of follicle formation by controlling the number of primordial follicles that initiate the maturation process, thus preventing the exhaustion of the quiescent follicles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrosurgical energy group | Active comparator | Procedure: laparoscopic ovarian cystectomy using electrosurgical energyin this group electrosurgical energy will be used to control bleeding |
| Hemostatic Sealant group | Active comparator | Procedure: laparoscopic ovarian cystectomy using hemostatic sealantin this group Hemostatic Sealant will be used to control bleeding |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old.
- Women with unilateral or bilateral benign ovarian cyst provisionally diagnosed by ultrasound and normal tumor markers.
- Women fit for laparoscopic surgery
Key exclusion criteria (7 listed)
- Pregnant women.
- Postmenopausal women.
- Premenarchal girls.
- Women with a history of recent pelvic or abdominal radiotherapy.
- Women with serious concurrent systemic disorders.
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 |
|---|---|---|
| laparoscopic ovarian cystectomy using hemostatic sealant* A small incision will be made on the ovarian surface using laparoscopic scissors. * Nontraumatic grasping forceps will be used to dissect the cyst capsule away from the soft tissue of the ovary. * The cyst will be removed intact to avoid spillage of its contents. If rupture occurs, the peritoneal cavity will be irrigated thoroughly. * After the removal of the cyst, the ovarian bed should be inspected for bleeding, and if there is minimal bleeding, using of electrocautery should be avoided to minimize thermal damage to the ovary. * The hemostatic sealant as Surgicel original, Surgicel Fibrillar (ETHICON, USA) which is an absorbable hemostat (oxidized regenerated cellulose) will be applied directly to the bleeding surface 1:5sheets of hemostat will be used. | Procedure or surgery | Hemostatic Sealant group |
| laparoscopic ovarian cystectomy using electrosurgical energyA small incision will be made on the ovarian surface using laparoscopic scissors. * Nontraumatic grasping forceps will be used to dissect the cyst capsule away from the soft tissue of the ovary. * The cyst will be removed intact to avoid spillage of its contents. If rupture occurs, the peritoneal cavity will be irrigated thoroughly. * After the removal of the cyst, the ovarian bed should be inspected for bleeding, and if there is minimal bleeding, using of electrocautery should be avoided to minimize thermal damage to the ovary In the electrosurgical energy using group the hemostasis method will be different and will be achieved using electrosurgical energy. * After the cyst removal and cyst bed examination, any bleeding will be carefully coagulated using bipolar electrosurgical energy * Minimal energy will be applied for short durations to reduce collateral thermal | Procedure or surgery | electrosurgical energy group |
Primary outcome
The primary outcome of this study will be the hemostasis time
Time frame: Day 1
The primary outcome of this study will be the hemostasis time
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 9 Apr 2025.
- 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.
mustafa farag ellkany, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic ovarian cystectomy using hemostatic sealant and laparoscopic ovarian cystectomy using electrosurgical energy in people with Ovarian Cysts, run by Kafrelsheikh University at 1 site in Egypt.
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 3 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 9 Apr 2025. 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 Egypt. 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 Aya Yasser Fawzy, M.B.B.C.H (01097659005, yaya86438@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of this study will be the hemostasis time (time frame: Day 1). 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 9 Apr 2025.