ClinicalTrials.gg
RecruitingNCT06913335Updated Apr 9, 2025

Comparison Between Electrosurgical Energy and Hemostatic Sealants on Hemostasis in Laparoscopic Ovarian Cystectomy

An interventional study of laparoscopic ovarian cystectomy using hemostatic sealant and laparoscopic ovarian cystectomy using electrosurgical energy in Ovarian Cysts, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Apr 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Ovarian Cysts with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Ovarian Cysts · Egypt.

Started
2025
the only one that year
No phase
8 of 10
2 open now
Registered
7th of 10
by date
Lead sponsor
1 of 10
Kafrelsheikh University

Among the 10 studies in Ovarian Cysts with a site in Egypt, this one is the only one that started in 2025, is one of 8 with no phase, and was the 7th registered.

Ovarian Cysts

80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.

Browse Ovarian Cysts studies →

Open to participants now

2 of the 10 studies in Ovarian Cysts with a site in Egypt are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 12 Ovarian Cysts studies recruiting now, 4 (33%) set no upper age limit and 7 (58%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.

This study: 18 Years to 50 Years · female · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Ovarian Cysts

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04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnant women.
  • women.
  • Premenarchal girls.
  • Women with a history of recent pelvic or abdominal radiotherapy.
  • Women with serious concurrent systemic disorders.
  • Known ovarian provisionally diagnosed by ultrasound (US) or tumor markers.
  • Women with coagulopathy or bleeding disorders.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
58 participants (estimated)

Study arms

  • Active comparator
    electrosurgical energy group

    in this group electrosurgical energy will be used to control bleeding

    Procedure: laparoscopic ovarian cystectomy using electrosurgical energy

  • Active comparator
    Hemostatic Sealant group

    in this group Hemostatic Sealant will be used to control bleeding

    Procedure: laparoscopic ovarian cystectomy using hemostatic sealant

Interventions

  • Procedurelaparoscopic 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.

  • Procedurelaparoscopic ovarian cystectomy using electrosurgical energy

    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

06

What researchers measure

Primary outcomes

  1. The primary outcome of this study will be the hemostasis time

    The primary outcome of this study will be the hemostasis time

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2025 (actual). Primary completion is estimated for Apr 2026, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2025
First posted
Apr 6, 2025
StartActual
Apr 1, 2025
Primary completionEst.
Apr 1, 2026
CompletionEst.
May 1, 2026
Last update
Apr 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06913335
Responsible party
Aya Yasser Fawzy (resident, Kafrelsheikh University) — Principal investigator
First posted
Apr 6, 2025
Start date
Apr 1, 2025
Primary completion
Apr 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Apr 9, 2025

Study contacts

Aya Yasser Fawzy, M.B.B.C.H
Contact
yaya86438@gmail.com
01097659005
mustafa farag ellkany, MD
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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