Laparoscopic MyomectomyNCT07200778
Reducing Operative Blood Loss in Laparoscopic Myomectomy With Umbilico-uterine Trunk Clipping
A study testing umbilico-uterine trunk occlusion and local epinephrine infiltration in people with Laparoscopic Myomectomy, run by Minia University at 1 site in Egypt.
Trial summary
the purpose of this study is to examine how Umbilico-uterine trunk occlusion reduces surgery-associated blood loss in Laparoscopic Myomectomy. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Laparoscopic Myomectomy
- What is being tested?
- umbilico-uterine trunk occlusion and local epinephrine infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Sep 2025to 11 Mar 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
- Age between 19 and 45
- Symptoms of menorrhagia, pelvic pain, or infertility
- Plan to have a laparoscopic myomectomy
- Number of myomas ≤ 4, with the largest myoma measuring ≤ 9 cm
Who cannot join
- Postmenopausal status
- Dominant pedunculated subserosal FIGO classification (6-7)
- Submucosal type of myoma FIGO classification (0-2)
- Suspicion of malignant uterine or adnexal diseases
- Major medical comorbidities or psychiatric illnesses that could affect follow-up and/or compliance
- Refusal to participate or provide consent to the procedures.
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
About this study
the purpose of this study is to examine how Umbilico-uterine trunk occlusion reduces surgery-associated blood loss in Laparoscopic Myomectomy.
- Conditions
- Laparoscopic Myomectomy
- Being tested
- umbilico-uterine trunk occlusion, local epinephrine infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilico-uterine trunk occlusionProcedure or surgery
participants will undergo umbilico-uterine trunk occlusion during laparoscopic myomectomy
local epinephrine infiltrationProcedure or surgery
participants will undergo local injections of epinephrine into the serosal and/or myometrium, covering the myoma before the uterine incision during laparoscopic myomectomy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | participants will undergo umbilico-uterine trunk occlusion Receives: Procedure: umbilico-uterine trunk occlusion |
| Group B | Active comparator | participants will undergo local injections of epinephrine into the serosal and/or myometrium, covering the myoma before the uterine incision Receives: Procedure: local epinephrine infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Blood Loss
The difference between the total amount of irrigation and suction will be used to compute operational blood loss
Measured: during operation
Hemoglobin drop
The difference between the preoperative and postoperative hemoglobin levels will be used to define the hemoglobin change.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start11 Sep 2025
- Primary completion11 Mar 2026 (estimated)
- Study completion11 Mar 2026 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 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
- NCT07200778
- Sponsor's protocol ID
- 1531-5-2025
- Status last verified
- Oct 2025
- First submitted
- 23 Sep 2025
- Last updated
- 7 Oct 2025
- 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 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Operative Blood Loss in Laparoscopic Myomectomy With Umbilico-uterine Trunk Clipping
- ClinicalTrials.gov ID
- NCT07200778
- Acronym / sponsor ID
- 1531-5-2025
- Conditions
- Laparoscopic Myomectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 11 Mar 2026 (estimated)
- Study completion
- 11 Mar 2026 (estimated)
- First posted
- 1 Oct 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 purpose of this study is to examine how Umbilico-uterine trunk occlusion reduces surgery-associated blood loss in Laparoscopic Myomectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: umbilico-uterine trunk occlusionparticipants will undergo umbilico-uterine trunk occlusion |
| Group B | Active comparator | Procedure: local epinephrine infiltrationparticipants will undergo local injections of epinephrine into the serosal and/or myometrium, covering the myoma before the uterine incision |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 19 and 45
- Symptoms of menorrhagia, pelvic pain, or infertility
- Plan to have a laparoscopic myomectomy
- Number of myomas ≤ 4, with the largest myoma measuring ≤ 9 cm
Key exclusion criteria (6 listed)
- Postmenopausal status
- Dominant pedunculated subserosal FIGO classification (6-7)
- Submucosal type of myoma FIGO classification (0-2)
- Suspicion of malignant uterine or adnexal diseases
- Major medical comorbidities or psychiatric illnesses that could affect follow-up and/or compliance
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 |
|---|---|---|
| umbilico-uterine trunk occlusionparticipants will undergo umbilico-uterine trunk occlusion during laparoscopic myomectomy | Procedure or surgery | Group A |
| local epinephrine infiltrationparticipants will undergo local injections of epinephrine into the serosal and/or myometrium, covering the myoma before the uterine incision during laparoscopic myomectomy | Procedure or surgery | Group B |
Primary outcome
Operative Blood Loss
Time frame: during operation
The difference between the total amount of irrigation and suction will be used to compute operational blood loss
Hemoglobin drop
Time frame: 24 hours postoperative
The difference between the preoperative and postoperative hemoglobin levels will be used to define the hemoglobin change.
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 7 Oct 2025.
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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 umbilico-uterine trunk occlusion and local epinephrine infiltration 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 4 inclusion and 6 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 7 Oct 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 Mohamed abdelghfar, Lecturer (+20 10 61624335, mohamedeleboany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Blood Loss (time frame: during operation). The study lists 2 primary outcomes in all. 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 7 Oct 2025.