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This study hypothesizes that temporary bilateral uterine and utero-ovarian artery occlusion with laparoscopic clamps at time of minimally invasive myomectomy will lead to a decreased blood loss at time of myomectomy compared to minimally invasive myomectomy without temporary occlusion.
Background: Leiomyomas are the most common benign tumor of the uterus and affect approximately 70-80% of the population with a uterus . Patients who opt to undergo treatment for a fibroid uterus have a variety of options including medical management, embolization, or surgical management; Historically surgical management involved hysterectomy; however, myomectomy has become more popular as a uterine sparing option. Current data supports that minimally invasive myomectomy is associated with lower morbidity and blood loss than traditional abdominal surgery. With advances in Minimally invasive myomectomy (MIS). There continues to be interest in methods to better improve intraoperative and postoperative outcomes. There is currently support for universal use of intramural vasopressin at time of myomectomy and a growing body of evidence to support temporary bilateral occlusion of the uterine and/or uteroovarian arteries at time of myomectomy to decrease blood loss.
High myoma burden is associated with an increased blood loss at time of surgical management.
Previous studies assessing the utility in temporary occlusion of the uterine and/or utero-ovarian vessels have not specifically evaluated the impact on high myoma burden individuals. As higher myoma burden is addressed in a minimally invasive fashion, it is important to specifically evaluate techniques to optimize these procedures. This study will specifically evaluate the effect of temporary bilateral uterine artery and utero-ovarian occlusion with laparoscopic clamps at the time of minimally invasive myomectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporary vessel clamps | Experimental | Use of temporary laparoscopic vessel clamps on uterine and ovarian vessels |
|
| No Temporary vessel clamps | No Intervention | No use of vessel clamps |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporary clamping of uterine and ovarian vessels | Other | Surgeon will temporarily clamp uterine and ovarian vessels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimated blood loss | Estimated blood loss during the surgery between groups, calculated by suction prior to irrigation. | Intraoperative (during surgery, which is < 24 hours) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with female reproductive organs
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Randa Jalloul, MD | Contact | 3137128603 | randa.j.jalloul@uth.tmc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D009214 | Myoma |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |