Laparoscopic MyomectomyNCT07525687
Temporary Uterine Tourniquet Application Versus Local Myometrial Epinephrine Injection During Laparoscopic Myomectomy
A study testing Temporary Uterine Tourniquet Application and Local Myometrial Epinephrine Injection in people with Laparoscopic Myomectomy, run by Minia University at 1 site in Egypt.
Trial summary
While both local vasoconstrictors and tourniquet application are recognized methods for blood loss control, there is a paucity of head-to-head randomized controlled trials directly comparing these two distinct approaches in laparoscopic myomectomy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Laparoscopic Myomectomy
- What is being tested?
- Temporary Uterine Tourniquet Application and Local Myometrial Epinephrine Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2026to 20 Jan 2027
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18-45 years.
- Diagnosed with symptomatic uterine leiomyomas requiring laparoscopic myomectomy.
- Presence of at least one myoma with a diameter ≥3 cm and ≤10 cm.
- Patients with up to 3 myomas (to standardize surgical complexity).
- Preoperative hemoglobin level ≥10 g/dL.
- Ability to provide informed consent.
Who cannot join
- Patients with more than 3 myomas or any myoma larger than 10 cm.
- Patients with suspected uterine malignancy (e.g., leiomyosarcoma).
- Patients with known bleeding disorders or on anticoagulant therapy that cannot be safely discontinued.
- Patients with significant cardiovascular disease, uncontrolled hypertension, or arrhythmias (relative contraindications for epinephrine).
- Patients with active pelvic infection.
- Patients with previous extensive uterine surgery (e.g., multiple prior myomectomies or extensive uterine reconstruction) that may compromise uterine integrity.
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- Patients undergoing concurrent major gynecological procedures that might significantly affect blood loss (e.g., hysterectomy, extensive adhesiolysis).
- Patients with known allergy to epinephrine.
- Patients unwilling or unable to comply with follow-up protocols.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Minia advanced laparoscopy unit
Minya
Mohamed abdelghfar, Lecturer, +20 10 61624335, mohamedeleboany@gmail.com
About this study
While both local vasoconstrictors and tourniquet application are recognized methods for blood loss control, there is a paucity of head-to-head randomized controlled trials directly comparing these two distinct approaches in laparoscopic myomectomy. Existing data often compare these methods to no intervention or to other less common techniques. A direct comparison is essential to determine which method offers superior hemostasis with an acceptable safety profile in the laparoscopic setting. This study aims to address this gap in the literature.
- Conditions
- Laparoscopic Myomectomy
- Being tested
- Temporary Uterine Tourniquet Application, Local Myometrial Epinephrine Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary Uterine Tourniquet ApplicationProcedure or surgery
The tourniquet will be tightened just enough to achieve visible blanching of the uterus, indicating adequate vascular occlusion, but without excessive tension to avoid tissue damage
Local Myometrial Epinephrine InjectionProcedure or surgery
Approximately 5-10 mL of the diluted epinephrine will be injected into the myometrium surrounding each fibroid, specifically at the base of the myoma and along the planned incision line, using a laparoscopic injection needle.
| Study group | Role | What they receive |
|---|---|---|
| Temporary Uterine Tourniquet Application | Active comparator | Not described Receives: Procedure: Temporary Uterine Tourniquet Application |
| Local Myometrial Epinephrine Injection | Active comparator | Not described Receives: Procedure: Local Myometrial Epinephrine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Blood Loss
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 posted13 Apr 2026
- Study start20 Apr 2026
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic MyomectomyStudies of the same condition, open and under way.
- More trials run by Minia 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
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassan Mohamed Abdel Ghfar, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525687
- Sponsor's protocol ID
- 1706-9-2025
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Uterine Tourniquet Application Versus Local Myometrial Epinephrine Injection During Laparoscopic Myomectomy
- ClinicalTrials.gov ID
- NCT07525687
- Acronym / sponsor ID
- 1706-9-2025
- Conditions
- Laparoscopic Myomectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 13 Apr 2026 (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.
While both local vasoconstrictors and tourniquet application are recognized methods for blood loss control, there is a paucity of head-to-head randomized controlled trials directly comparing these two distinct approaches in laparoscopic myomectomy. Existing data often compare these methods to no intervention or to other less common techniques. A direct comparison is essential to determine which method offers superior hemostasis with an acceptable safety profile in the laparoscopic setting. This study aims to address this gap in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporary Uterine Tourniquet Application | Active comparator | Procedure: Temporary Uterine Tourniquet Application |
| Local Myometrial Epinephrine Injection | Active comparator | Procedure: Local Myometrial Epinephrine Injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female patients aged 18-45 years.
- Diagnosed with symptomatic uterine leiomyomas requiring laparoscopic myomectomy.
- Presence of at least one myoma with a diameter ≥3 cm and ≤10 cm.
- Patients with up to 3 myomas (to standardize surgical complexity).
- Preoperative hemoglobin level ≥10 g/dL.
Key exclusion criteria (9 listed)
- Patients with more than 3 myomas or any myoma larger than 10 cm.
- Patients with suspected uterine malignancy (e.g., leiomyosarcoma).
- Patients with known bleeding disorders or on anticoagulant therapy that cannot be safely discontinued.
- Patients with significant cardiovascular disease, uncontrolled hypertension, or arrhythmias (relative contraindications for epinephrine).
- Patients with active pelvic infection.
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 |
|---|---|---|
| Temporary Uterine Tourniquet ApplicationThe tourniquet will be tightened just enough to achieve visible blanching of the uterus, indicating adequate vascular occlusion, but without excessive tension to avoid tissue damage | Procedure or surgery | Temporary Uterine Tourniquet Application |
| Local Myometrial Epinephrine InjectionApproximately 5-10 mL of the diluted epinephrine will be injected into the myometrium surrounding each fibroid, specifically at the base of the myoma and along the planned incision line, using a laparoscopic injection needle. | Procedure or surgery | Local Myometrial Epinephrine Injection |
Primary outcome
Intraoperative Blood Loss
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 21 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Uterine Tourniquet Application and Local Myometrial Epinephrine Injection in people with Laparoscopic Myomectomy, run by Minia 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 6 inclusion and 9 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 21 Jul 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Blood Loss (time frame: During 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 21 Jul 2026.