EndometriomaNCT06421857
Hemostatic Measures During Laparoscopic Cystectomy for Endometrioma
A study testing suturing and bipolar electrocoagulation in people with Endometrioma, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
laparoscopic excision of ovarian endometriotic cysts is generally recommended because it has been associated with a higher spontaneous conception rate, residual ovarian function after the procedure may be affected Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Endometrioma
- What is being tested?
- suturing and bipolar electrocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 May 2024
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 35 years
- unilateral endometriotic cyst
Who cannot join
- anovulatory women women with decreased ovarian reserve women receiving hormonal treatment three months prior to surgery women with any contraindication to laparoscopy women with previous ovarian surgery possible ovarian malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bipolar Coagulation Versus Suturing During Laparoscopic Endometriotic Cystectomy
laparoscopic excision of ovarian endometriotic cysts is generally recommended because it has been associated with a higher spontaneous conception rate, residual ovarian function after the procedure may be affected
- Conditions
- Endometrioma
- Being tested
- suturing, bipolar electrocoagulation
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suturingProcedure or surgery
laparoscopic cystectomy for endometrioma and hemostasis was done using suturing
bipolar electrocoagulationProcedure or surgery
laparoscopic cystectomy for endometrioma and hemostasis was done bipolar electrocoagulation
| Study group | Role | What they receive |
|---|---|---|
| suturing | Active comparator | after ovarian cystectomy for endometrioma, separate sutures were applied if there was significant bleeding Receives: Procedure: suturing |
| bipolar electrocoagulation | Active comparator | after ovarian cystectomy for endometrioma, the inner wall was coagulated using bipolar electrocoagulation if there was significant bleeding Receives: Procedure: bipolar electrocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovarian reserve
measuring AMH level
Measured: 6 weeks after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Sep 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriomaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagat Hesham Abdelhai Mohammed, Ain Shams Maternity Hospital
- Investigators
- Osama Kamel, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421857
- Sponsor's protocol ID
- ASU Hemostasis
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Coagulation Versus Suturing During Laparoscopic Endometriotic Cystectomy
- ClinicalTrials.gov ID
- NCT06421857
- Acronym / sponsor ID
- ASU Hemostasis
- Conditions
- Endometrioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 20 May 2024 (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.
laparoscopic excision of ovarian endometriotic cysts is generally recommended because it has been associated with a higher spontaneous conception rate, residual ovarian function after the procedure may be affected
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suturing | Active comparator | Procedure: suturingafter ovarian cystectomy for endometrioma, separate sutures were applied if there was significant bleeding |
| bipolar electrocoagulation | Active comparator | Procedure: bipolar electrocoagulationafter ovarian cystectomy for endometrioma, the inner wall was coagulated using bipolar electrocoagulation if there was significant bleeding |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 to 35 years
- unilateral endometriotic cyst
Key exclusion criteria (1 listed)
- anovulatory women women with decreased ovarian reserve women receiving hormonal treatment three months prior to surgery women with any contraindication to laparoscopy women with previous ovarian surgery possible ovarian malignancy.
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 |
|---|---|---|
| suturinglaparoscopic cystectomy for endometrioma and hemostasis was done using suturing | Procedure or surgery | suturing |
| bipolar electrocoagulationlaparoscopic cystectomy for endometrioma and hemostasis was done bipolar electrocoagulation | Procedure or surgery | bipolar electrocoagulation |
Primary outcome
ovarian reserve
Time frame: 6 weeks after procedure
measuring AMH level
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 20 May 2024.
- 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. This study is not recruiting at the moment.
Osama Kamel, MD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suturing and bipolar electrocoagulation in people with Endometrioma, run by Ain Shams Maternity Hospital 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 2 inclusion and 1 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 20 May 2024. 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?
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?
ovarian reserve (time frame: 6 weeks after procedure). 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 20 May 2024.