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临床试验/NCT05154279
NCT05154279招募中不适用

The Effect of Intramyometrial Injection of Terlipressin Versus Intramyometrial Injection of Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations: Double Blinded Randomized Placebo-Controlled Trial

Wael Elbanna Clinic2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2022年2月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
99
试验地点
2
主要终点
effect of intramyometrial terlipressin vs carbitocin vs saline on decreasing blood loss in laparoscopic myomectomy

研究概览

简要总结

Our study aims to evaluate the efficacy of intramyometrial injection of Terlipressin versus intramyometrial injection of Carbetocin on hemoglobin level in women undergoing abdominal myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.

详细描述

Fibroids are firm benign tumors that are made of smooth muscle cells and fibrous connective tissue. Benign uterine leiomyomas (fibroids) are the most common pelvic tumor in women, affecting 20-40% of all women over the age of 35 and 50% of African American women. Approximately 20-40% of women with fibroids experience significant symptoms and consult gynecologic care. However, their true prevalence is probably underestimated . The most common clinical symptoms include abnormal uterine bleeding, dysmenorrhea, pelvic pain, infertility, and recurrent pregnancy loss . Less commonly, women with a uterine mass presumed to be a leiomyoma are found to have a uterine sarcoma or a leiomyoma variant Although hysterectomy is the definitive treatment for myomas, myomectomy remains the gold-standard treatment for women wishing to preserve their uterus and fertility . However, bleeding is often a problem in a myomectomy and can result in intra-operative hypovolaemic shock, post-operative anemia, and delayed recovery .

Three common causes of increased blood loss during abdominal myomectomy are poor surgical technique, the complexity of intra-abdominal pathology (such as low corpus, intra- ligamentous myomas, or obliteration of culde-sac), and the excessive loss of intrauterine blood during dissection of the myomas .

The current treatments for uterine fibroids are many, medical as progesterone's and progesterone antagonist's, surgical, and recent myoma therapies as uterine artery embolization, but surgical resection is still the main treatment, including hysterectomy and myomectomy. With hysterectomy, uterine fibroids can be completely cured, but it cannot keep women's reproductive functions. Despite the rate of relapse, myomectomy is still the most popular surgical treatment for fibroids in women .

A myomectomy excises the fibroid(s) and repairs any defect in the uterine wall, while preserving the uterus. For this reason, myomectomy is an option for women who desire future pregnancies or who wish to retain their uterus. After myomectomy, fibroids could recur, which could lead to subsequent intervention(s) . A laparoscope can be used to remove the fibroid(s) through small incisions in the abdominal wall (laparoscopic) or a hysteroscope can be used to reach the fibroid(s) through the cervix (hysteroscopic).

Although laparoscopic myomectomy has been performed since Semm and colleagues described the procedure in late 1970s , the role of laparoscopic myomectomy as a treatment option for symptomatic uterine fibroids has been questioned. Many fibroids that can be easily removed laparoscopically may not require surgical intervention .

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 16-45 years
  • Appropriate medical status for laparoscopic surgery (largest myoma ≤15 cm)
  • Baseline hemoglobin ≥9 g/dl
  • No contra-indications to the use of glyopressin or carbitocin
  • Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility
  • Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks)

排除标准

  • Previous myomectomy
  • History of bleeding disorders
  • Concurrent anticoagulation therapy
  • History of Uncontrolled ischaemic heart disease
  • Any pelvic abnormalities requiring concomitant surgery
  • Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
  • Inability to understand and provide written informed consent.

研究组 & 干预措施

intramyometrial Terlipressin

Active Comparator

intramyometrial injection of Terlipressin in women undergoing laparoscopic myomectomy procedure

干预措施: Terlipressin (Drug)

intramyometrial carbitocin

Active Comparator

intramyometrial injection of Carbetocin in women undergoing laparoscopic myomectomy procedure

干预措施: Terlipressin (Drug)

intramyometrial saline

Placebo Comparator

intramyometrial injection of saline in women undergoing laparoscopic myomectomy procedure

干预措施: Terlipressin (Drug)

结局指标

主要结局

effect of intramyometrial terlipressin vs carbitocin vs saline on decreasing blood loss in laparoscopic myomectomy

时间窗: 12 hours

1- To evaluate the efficacy of intramyometrial injection of Terlipressin versus intramyometrial injection of Carbetocin in decreasing blood loss in women undergoing laparoscopic myomectomy

次要结局

  • effect of intramyometrial terlipressin vs carbitocin vs saline on decrease hemoglobin level in laparoscopic myomectomy(24 hours)
  • effect of intramyometrial terlipressin vs carbitocin vs saline on operative time(12 hours)

研究者

发起方
Wael Elbanna Clinic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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