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临床试验/NCT06566352
NCT06566352招募中不适用

Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy; A Randomized Controlled Clinical Trial

Zagazig University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月1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
入组人数
60
试验地点
1
主要终点
blood loss

研究概览

简要总结

Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation and hospitalization period after laparoscopic myomectomy.

详细描述

Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation, and hospitalization period after laparoscopic myomectomy.

This will be the first study to investigate the efficacy of Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine in minimizing blood loss during Laparoscopic myomectomy at our university.

Can Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine give better outcomes regarding intraoperative bleeding when compared to traditional 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
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged from 18 to 39 years.
  • Symptomatizing Women (heavy menstrual bleeding or subfertility).
  • FIGO stage (3-7) by ultrasound.
  • Only uterine corpus fibroid.
  • Up to three fibroids by ultrasound.
  • No previous hormonal treatment.

排除标准

  • Patients with bleeding tendency.
  • Patients who refuse to participate in the study or uncooperative patients.
  • Current pregnancy.
  • Any retroperitoneal surgery at pararectal space.
  • More than one cesarean delivery.

研究组 & 干预措施

laparoscopic myomectomy with temporary bilateral uterine artery occlusion

Experimental

laparoscopic myomectomy with temporary bilateral uterine artery occlusion

干预措施: laparoscopic myomectomy with temporary bilateral uterine artery occlusion (Procedure)

Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine

Experimental

Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine

干预措施: Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine (Procedure)

Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine

Experimental

Laparoscopic myomectomy with intramyometrial injection of diluted epinephrine

干预措施: injection of epinephrine 1mg diluted in 200mg of NaCl (Drug)

traditional laparoscopic myomectomy

Experimental

traditional laparoscopic myomectomy

干预措施: traditional laparoscopic myomectomy (Procedure)

结局指标

主要结局

blood loss

时间窗: intra-operative

estimated blood loss

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ahmed Nashat Fatah Allah Omran

Obstetrics and Gynecology Department Zagazig University

Zagazig University

研究点 (1)

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