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| Name | Class |
|---|---|
| Kafrelsheikh University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Uterine Artery Ligation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During surgery and until drain removal on the second postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Need for blood transfusion | Number of participants requiring blood transfusion as an indicator of significant perioperative hemorrhage. | From surgery until hospital discharge, assessed up to 3 days. |
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Inclusion Criteria:
Exclusion Criteria:
Women scheduled for elective transabdominal myomectomy for symptomatic uterine fibroids will be recruited from the gynecology wards and outpatient clinics at Kasr Al-Ainy Hospital.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maged Elmohamady Rashedy, MD | Contact | 01090013685 | Magedalmohamady50@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | Al-Manial | 11956 | Egypt |
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| ID | Term |
|---|---|
| D047708 | Myofibroma |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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.
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This study is designed as a double-blind randomized clinical trial. Participants will be blinded to the assigned hemostatic technique during transabdominal myomectomy. Randomization will be performed using computer-generated allocation with sequentially numbered opaque sealed envelopes, and the allocation code will be kept by an independent supervisor. Outcome assessment and postoperative data collection will be performed without disclosure of group assignment. The operating surgical team will perform the assigned procedure intraoperatively according to the randomization code.
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| Pericervical Mechanical Tourniquet Application | Procedure | 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 |
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| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |