Myoma;UterusNCT07526311
Reducing Blood Loss During Myomectomy:Uterine Artery Ligation Vs Pericervical Tourniquet
A study testing Bilateral Uterine Artery Ligation and Pericervical Mechanical Tourniquet Application in people with Myoma;Uterus and Blood Loss, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare two surgical techniques for reducing blood loss during transabdominal myomectomy in women with symptomatic uterine fibroids. The main question it aims to answer is whether bilateral uterine artery ligation reduces intraoperative blood loss more effectively than… Read more about this study
- Who is it for?
- Ages 25 to 48 years, women only
- Conditions the study is for
- Myoma;Uterus, Blood Loss
- What is being tested?
- Bilateral Uterine Artery Ligation and Pericervical Mechanical Tourniquet Application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2026to 10 Apr 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 25 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 25 to 48 years
- Body mass index less than 35 kg/m²
- Symptomatic uterine myomas requiring surgical treatment
- Intramural myomas classified as FIGO types 3 to 6
- Diagnosis confirmed by transvaginal ultrasound and/or magnetic resonance imaging
- Maximum diameter of the largest myoma 20 cm or less
- Scheduled for elective transabdominal myomectomy
- Able and willing to provide written informed consent
Who cannot join
- Submucosal, intracavitary, pedunculated subserosal, cervical, or adnexal myomas
- FIGO types 0, 1, 2, 7, or 8 myomas
- History of pelvic inflammatory disease or peritonitis
- Previous abdominal or pelvic surgery for non-obstetric causes
- Previous uterine surgery
- Use of hormonal therapy within the previous 3 months
Show all 11Show fewer
- Known bleeding disorder
- Use of anticoagulant or antiplatelet therapy
- Preoperative hemoglobin less than 10 g/dL
- Body mass index 35 kg/m² or greater
- Intraoperative conversion from myomectomy to hysterectomy
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
Cairo University
Cairo, Al-Manial, 11956
Abd el megeed Mahfouz Qasem, MD, +2 3649281, scholar@cu.edu.eg
About this study
Official title: Bilateral Uterine Artery Ligation Versus Pericervical Mechanical Tourniquet Application in Reducing Intraoperative Blood Loss During Transabdominal Myomectomy.
The goal of this clinical trial is to compare two surgical techniques for reducing blood loss during transabdominal myomectomy in women with symptomatic uterine fibroids. The main question it aims to answer is whether bilateral uterine artery ligation reduces intraoperative blood loss more effectively than pericervical mechanical tourniquet application, without increasing operative complications. Researchers will compare bilateral uterine artery ligation with pericervical mechanical tourniquet application during open myomectomy to evaluate blood loss and surgical safety. Participants will undergo elective transabdominal myomectomy and will be randomly assigned to one of the two vascular control techniques before myoma enucleation.
Read the detailed description
Uterine fibroids are among the most common benign gynecologic tumors and may cause heavy menstrual bleeding, pelvic pain, pressure symptoms, infertility, and other reproductive problems. For women who desire uterine preservation, myomectomy remains an important treatment option. In patients with large, multiple, or deeply located fibroids, transabdominal myomectomy is still widely performed. However, one of its major challenges is significant intraoperative bleeding, which may increase operative difficulty, prolong surgery, increase postoperative morbidity, and raise the need for blood transfusion.
Several methods have been used to reduce bleeding during myomectomy. Among the commonly used surgical approaches are bilateral uterine artery ligation and pericervical mechanical tourniquet application. Bilateral uterine artery ligation reduces uterine arterial inflow before myoma enucleation and may provide sustained hemostasis during surgery. Pericervical tourniquet application is a simple mechanical method that temporarily compresses the uterine vessels at the cervico-isthmic level during the procedure. Although both techniques are used in practice, comparative evidence remains limited, and further evaluation is needed to determine the more effective and safe method for blood loss reduction during fertility-sparing surgery.
This study is a prospective, randomized, comparative clinical trial conducted at the Department of Obstetrics and Gynecology, Kasr Al-Ainy Hospital, Cairo University, Egypt. Women scheduled for elective transabdominal myomectomy for symptomatic uterine fibroids will be recruited and randomized into two parallel groups. One group will undergo bilateral uterine artery ligation before myoma enucleation, while the other group will undergo pericervical mechanical tourniquet application using a Foley catheter at the level of the internal os before myoma enucleation. All procedures will be performed by the same experienced surgical team under standardized perioperative conditions to reduce inter-operator variability.
During surgery, after the assigned vascular control technique is applied, myoma enucleation and uterine repair will proceed according to a standardized operative technique. Blood loss assessment will include intraoperative blood loss measured from surgical swabs and suctioned blood, as well as postoperative blood loss measured from the intraperitoneal drain. The trial is designed to determine whether bilateral uterine artery ligation provides superior hemostatic control compared with pericervical mechanical tourniquet application, while also evaluating perioperative safety and recovery outcomes.
- Conditions
- Myoma;Uterus, Blood Loss
- Being tested
- Bilateral Uterine Artery Ligation, Pericervical Mechanical Tourniquet Application
- Keywords
- uterine artery ligation, peri cervical mechanical tourniquet, blood loss, myomectomy
- Medical subject headings
- Myofibroma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Uterine Artery LigationProcedure or surgery
Also called Uterine artery ligation
A surgical hemostatic procedure performed before myoma enucleation during transabdominal myomectomy to reduce uterine arterial blood flow and intraoperative bleeding. Bilateral ligation is carried out at the level of the internal cervical os using absorbable sutures as part of the assigned vascular control technique.
Pericervical Mechanical Tourniquet ApplicationProcedure or surgery
Also called Pericervical tourniquet, Foley catheter tourniquet
A temporary mechanical vascular control technique performed before myoma enucleation during transabdominal myomectomy to reduce uterine blood flow and intraoperative bleeding. A sterile Foley catheter is placed around the cervico-isthmic region at the level of the internal os and removed after uterine repair and hemostasis are completed
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Uterine Artery Ligation | Experimental | Participants assigned to this arm will undergo transabdominal myomectomy with bilateral uterine artery ligation performed before myoma enucleation. The uterine arteries will be identified bilaterally near the level of the internal cervical os and ligated using absorbable sutures to reduce uterine blood flow during surgery. Myoma enucleation and uterine repair will then be completed according to the study protocol. Receives: Procedure: Bilateral Uterine Artery Ligation |
| Pericervical Mechanical Tourniquet | Experimental | Participants assigned to this arm will undergo transabdominal myomectomy with application of a pericervical mechanical tourniquet before myoma enucleation. A sterile Foley catheter will be passed around the cervico-isthmic region at the level of the internal os and tied firmly to compress the uterine vessels during surgery. The tourniquet will remain in place throughout myoma enucleation and uterine repair and will be removed after completion of hemostasis. Receives: Procedure: Pericervical Mechanical Tourniquet Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated blood loss
Total blood loss measured as the sum of intraoperative blood loss and postoperative blood loss. Intraoperative blood loss will be assessed by weighing surgical swabs and measuring suctioned blood volume, while postoperative blood loss will be measured from the intraperitoneal drain.
Measured: During surgery and until drain removal on the second postoperative day
Secondary outcomes (1)
Need for blood transfusion
Number of participants requiring blood transfusion as an indicator of significant perioperative hemorrhage.
Measured: From surgery until hospital discharge, assessed up to 3 days.
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 start10 Apr 2026 (estimated)
- Primary completion10 Mar 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myoma;UterusStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into 2 parallel groups undergoing transabdominal myomectomy. One group will receive bilateral uterine artery ligation before myoma enucleation, and the other group will receive pericervical mechanical tourniquet application before myoma enucleation. Outcomes will be compared between the 2 concurrently assigned groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Principal investigator, ahmed nagy shaker ramadan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526311
- Sponsor's protocol ID
- Cairo-MD-2026
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Uterine Artery Ligation Versus Pericervical Mechanical Tourniquet Application in Reducing Intraoperative Blood Loss During Transabdominal Myomectomy.
- ClinicalTrials.gov ID
- NCT07526311
- Acronym / sponsor ID
- Cairo-MD-2026
- Conditions
- Myoma;Uterus, Blood Loss
- Keywords
- uterine artery ligation, peri cervical mechanical tourniquet, blood loss, myomectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 10 Apr 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.
The goal of this clinical trial is to compare two surgical techniques for reducing blood loss during transabdominal myomectomy in women with symptomatic uterine fibroids. The main question it aims to answer is whether bilateral uterine artery ligation reduces intraoperative blood loss more effectively than pericervical mechanical tourniquet application, without increasing operative complications. Researchers will compare bilateral uterine artery ligation with pericervical mechanical tourniquet application during open myomectomy to evaluate blood loss and surgical safety. Participants will undergo elective transabdominal myomectomy and will be randomly assigned to one of the two vascular control techniques before myoma enucleation.
Detailed description
Uterine fibroids are among the most common benign gynecologic tumors and may cause heavy menstrual bleeding, pelvic pain, pressure symptoms, infertility, and other reproductive problems. For women who desire uterine preservation, myomectomy remains an important treatment option. In patients with large, multiple, or deeply located fibroids, transabdominal myomectomy is still widely performed. However, one of its major challenges is significant intraoperative bleeding, which may increase operative difficulty, prolong surgery, increase postoperative morbidity, and raise the need for blood transfusion.
Several methods have been used to reduce bleeding during myomectomy. Among the commonly used surgical approaches are bilateral uterine artery ligation and pericervical mechanical tourniquet application. Bilateral uterine artery ligation reduces uterine arterial inflow before myoma enucleation and may provide sustained hemostasis during surgery. Pericervical tourniquet application is a simple mechanical method that temporarily compresses the uterine vessels at the cervico-isthmic level during the procedure. Although both techniques are used in practice, comparative evidence remains limited, and further evaluation is needed to determine the more effective and safe method for blood loss reduction during fertility-sparing surgery.
This study is a prospective, randomized, comparative clinical trial conducted at the Department of Obstetrics and Gynecology, Kasr Al-Ainy Hospital, Cairo University, Egypt. Women scheduled for elective transabdominal myomectomy for symptomatic uterine fibroids will be recruited and randomized into two parallel groups. One group will undergo bilateral uterine artery ligation before myoma enucleation, while the other group will undergo pericervical mechanical tourniquet application using a Foley catheter at the level of the internal os before myoma enucleation. All procedures will be performed by the same experienced surgical team under standardized perioperative conditions to reduce inter-operator variability.
During surgery, after the assigned vascular control technique is applied, myoma enucleation and uterine repair will proceed according to a standardized operative technique. Blood loss assessment will include intraoperative blood loss measured from surgical swabs and suctioned blood, as well as postoperative blood loss measured from the intraperitoneal drain. The trial is designed to determine whether bilateral uterine artery ligation provides superior hemostatic control compared with pericervical mechanical tourniquet application, while also evaluating perioperative safety and recovery outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into 2 parallel groups undergoing transabdominal myomectomy. One group will receive bilateral uterine artery ligation before myoma enucleation, and the other group will receive pericervical mechanical tourniquet application before myoma enucleation. Outcomes will be compared between the 2 concurrently assigned groups.
| Arm | Type | Receives |
|---|---|---|
| Bilateral Uterine Artery Ligation | Experimental | Procedure: Bilateral Uterine Artery LigationParticipants assigned to this arm will undergo transabdominal myomectomy with bilateral uterine artery ligation performed before myoma enucleation. The uterine arteries will be identified bilaterally near the level of the internal cervical os and ligated using absorbable sutures to reduce uterine blood flow during surgery. Myoma enucleation and uterine repair will then be completed according to the study protocol. |
| Pericervical Mechanical Tourniquet | Experimental | Procedure: Pericervical Mechanical Tourniquet ApplicationParticipants assigned to this arm will undergo transabdominal myomectomy with application of a pericervical mechanical tourniquet before myoma enucleation. A sterile Foley catheter will be passed around the cervico-isthmic region at the level of the internal os and tied firmly to compress the uterine vessels during surgery. The tourniquet will remain in place throughout myoma enucleation and uterine repair and will be removed after completion of hemostasis. |
Who may qualify
- Ages
- 25 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
Key exclusion criteria (11 listed)
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 |
|---|---|---|
| Bilateral Uterine Artery LigationAlso: Uterine artery ligationA surgical hemostatic procedure performed before myoma enucleation during transabdominal myomectomy to reduce uterine arterial blood flow and intraoperative bleeding. Bilateral ligation is carried out at the level of the internal cervical os using absorbable sutures as part of the assigned vascular control technique. | Procedure or surgery | Bilateral Uterine Artery Ligation |
| Pericervical Mechanical Tourniquet ApplicationAlso: Pericervical tourniquet, Foley catheter tourniquetA temporary mechanical vascular control technique performed before myoma enucleation during transabdominal myomectomy to reduce uterine blood flow and intraoperative bleeding. A sterile Foley catheter is placed around the cervico-isthmic region at the level of the internal os and removed after uterine repair and hemostasis are completed | Procedure or surgery | Pericervical Mechanical Tourniquet |
Primary outcome
Estimated blood loss
Time frame: During surgery and until drain removal on the second postoperative day
Total blood loss measured as the sum of intraoperative blood loss and postoperative blood loss. Intraoperative blood loss will be assessed by weighing surgical swabs and measuring suctioned blood volume, while postoperative blood loss will be measured from the intraperitoneal drain.
1 secondary outcome
Need for blood transfusion
Time frame: From surgery until hospital discharge, assessed up to 3 days.
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 13 Apr 2026.
- Individual participant dataSharing planned: Yes
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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 Bilateral Uterine Artery Ligation and Pericervical Mechanical Tourniquet Application in people with Myoma;Uterus and Blood Loss, run by Cairo 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 8 inclusion and 11 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 13 Apr 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?
Contact Maged Elmohamady Rashedy, MD (01090013685, Magedalmohamady50@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated blood loss (time frame: During surgery and until drain removal on the second postoperative day). 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 13 Apr 2026.