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临床试验/NCT05994560
NCT05994560已完成不适用

Valor de la oclusión Temporal de Las Arterias Uterinas en la miomectomía Por Laparoscopia

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Blood loss during surgery

研究概览

简要总结

The objective of this study is to determine whether patients undergoing laparoscopic myomectomy with temporary occlusion of the uterine arteries and utero-ovarian ligaments using clips experience a decrease in blood loss during surgery compared to patients who undergo laparoscopic myomectomy without clips.

详细描述

Introduction:

Uterine fibroids are the most common benign tumors originating in the smooth muscle of the female genital tract. They occur in approximately 70% of women of middle age. Often, they cause abnormal uterine bleeding, pain, pelvic pressure, urinary and intestinal symptoms, and/or pregnancy complications. However, many fibroids are small and asymptomatic. About 25% of white women and 50% of black women will develop symptomatic fibroids. Fibroids are more common among overweight or obese women. Potential protective factors for fibroid occurrence are pregnancies and smoking, with a possible causal relationship, although the exact mechanism is not clear.

The treatment for women with uterine fibroids should be individualized based on their symptoms, size and location of fibroids, age, the need and desire to preserve fertility or the uterus, the availability of therapy, and the surgeon's experience. While hysterectomy is the definitive surgical treatment for symptomatic fibroids in women who do not wish to preserve fertility or their uterus, myomectomy is the treatment of choice for those with unfulfilled reproductive desires or a clear desire to keep their uterus and who are not suitable candidates for medical treatment.

The surgical planning for myomectomy should be based on the location, size, and number of fibroids, aided by appropriate imaging tests such as high-resolution ultrasound or magnetic resonance imaging (MRI).

Justification of the Study:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with uterine fibroids requiring surgical treatment via laparoscopy and with a desire to preserve the uterus.

排除标准

  • Patients who do not meet the inclusion criteria.
  • Women with symptomatic fibroids who are not candidates for laparoscopic surgery and/or have no desire to preserve the uterus.
  • Patients for whom technical placement of clips during the intervention is not possible.

结局指标

主要结局

Blood loss during surgery

时间窗: during the time of the surgery

The estimated intraoperative blood loss was calculated by measuring the amount of aspirated fluid at the end of the procedure minus the amount of fluid used for irrigation.

次要结局

  • To compare the surgical time of each technique(during surgery)
  • Length of hospital stay(until 1 week)
  • Difference in pre and postoperative hemoglobin levels (Hemoglobin loss)(up to 24 hours after surgery)

研究者

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

enrique moratalla bartolome

Principal Investigator

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

研究点 (2)

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