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临床试验/NCT07182045
NCT07182045招募中不适用

Impact of Uterine and Ovarian Vessel Occlusion on Blood Loss in High Burden Minimally Invasive Myomectomy.

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Estimated blood loss

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Patient undergoing minimally invasive myomectomy with either a single intramural or Submucosal fibroid =/>5cm or
  • •Patients undergoing minimally invasive Myomectomy with =/> 5 fibroids

排除标准

  • •Pregnancy,
  • •Age <18yo,
  • •Patients undergoing concomitant surgery such as endometriosis surgery,
  • •Suspected malignancy

研究组 & 干预措施

Temporary vessel clamps

Experimental

Use of temporary laparoscopic vessel clamps on uterine and ovarian vessels

干预措施: Temporary clamping of uterine and ovarian vessels (Other)

No Temporary vessel clamps

No Intervention

No use of vessel clamps

结局指标

主要结局

Estimated blood loss

时间窗: Intraoperative (during surgery, which is < 24 hours)

Estimated blood loss during the surgery between groups, calculated by suction prior to irrigation.

次要结局

未报告次要终点

研究者

发起方
The University of Texas Health Science Center, Houston
申办方类型
Other
责任方
Principal Investigator
主要研究者

Randa Jalloul

Associate Professor

The University of Texas Health Science Center, Houston

研究点 (1)

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