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临床试验/NCT07200778
NCT07200778招募中不适用

Reducing Operative Blood Loss in Laparoscopic Myomectomy With Umbilico-uterine Trunk Clipping

Minia University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年9月11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
66
试验地点
1
主要终点
Operative Blood Loss

研究概览

简要总结

the purpose of this study is to examine how Umbilico-uterine trunk occlusion reduces surgery-associated blood loss in Laparoscopic Myomectomy.

研究设计

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

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Group A

Experimental

participants will undergo umbilico-uterine trunk occlusion

干预措施: umbilico-uterine trunk occlusion (Procedure)

Group B

Active Comparator

participants will undergo local injections of epinephrine into the serosal and/or myometrium, covering the myoma before the uterine incision

干预措施: local epinephrine infiltration (Procedure)

结局指标

主要结局

Operative Blood Loss

时间窗: during operation

The difference between the total amount of irrigation and suction will be used to compute operational blood loss

Hemoglobin drop

时间窗: 24 hours postoperative

The difference between the preoperative and postoperative hemoglobin levels will be used to define the hemoglobin change.

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Hassan Mohamed Abdel Ghfar

Lecturer of Obstetrics and Gynecology

Minia University

研究点 (1)

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