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临床试验/NCT07365969
NCT07365969已完成不适用

The Risk of Hysterectomy at Time of Myomectomy at Ain Shams University Hospital: A Retrospective Cohort Study.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 293 人开始时间: 2024年12月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
293
试验地点
1
主要终点
Incidence of hysterectomy at time of myomectomy.

研究概览

简要总结

Uterine fibroids are the commonest tumor affecting the female reproductive tract and many instances they are asymptomatic but in some women there does appear to be an association with heavy menstrual blood loss and possibly subfertility. Classically, treatment has been surgical with hysterectomy the most common approach for women who have completed their fertility and myomectomy for those who wish to conceive. The surgery can be carried out laparoscopically, vaginally and abdominally. The aim of this study is to evaluate the risk of hysterectomy at the time of myomectomy, and the associated 30-day postoperative morbidity.

详细描述

Uterine fibroids are the most common benign tumors in reproductive age women affecting up to 80% of women (Havryliuk et al., 2017; Fortin et al., 2018). The cumulative incidence of uterine fibroids by age 50 years can be as high as 70% in white women and more than 80% in black women (Laughlin-Tommaso., 2016).

In many women, myomas may be asymptomatic and are diagnosed incidentally on clinical examination or imaging. 20% to 50% of patients with myoma experience symptoms, such as pelvic pain, heavy menstrual bleeding (HMB), iron deficiency anemia, pressure symptoms, or infertility (Bosteels et al., 2018).Treatment options for uterine fibroids include expectant, medical, or surgical management or by interventional radiology. The ideal treatment should be tailored according to the size, and location of the fibroid, in addition to the patient's age, symptoms, desire for future fertility and physician experience (Evangelisti et al., 2022).

Medical treatment is the hormonal therapy, which can cause shrinkage in the size of myoma, and relieve symptoms but it does not eliminate the disease and that's why if it is effective, it should be used chronically (Evangelisti et al., 2022).

Treatment by interventional radiology could provide an alternative, such as uterine artery embolization (UAE), high-intensity focused ultrasound, or transcervical radiofrequency ablation (Hartmann et al., 2017). In Uterine artery embolization, embolic agents are injected into the arteries that supply the uterus to cut off blood flow to fibroids, causing them to shrink and die that will relieve the symptoms. (Spies JB., 2016) Complications may happen if the blood supply to the ovaries or other organs is reduced. Radiofrequency ablation destroys uterine fibroids and shrinks the blood vessels that feed them, it can be performed through laparoscopy or through transvaginal or transcervical approach(Bradely et al .,2019) In recent years, it has been reported that UAE enables myomectomy with only minimal blood loss. Thereby devascularizing the leiomyoma and allowing for bloodless dissection (McLucas and Voorhees, 2015). This combination of two established procedures is intended to preserve the uterus in women with large and multiple fibroids who are at risk for blood loss including subsequent transfusions as well as conversion to hysterectomy.

Among uterus-preserving therapeutic options, myomectomy is the most widely performed intervention. Yet, for patients with myomas that are large, numerous, or unfavorably located, myomectomy is associated with an elevated risk for intraoperative bleeding and hysterectomy because of tumor-related neovascularization and anatomy distortion (Lethaby et al., 2017; Vargas MV et al., 2017).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women planned for abdominal myomectomy in the previous 4 years.
  • Availability of complete medical records for pre-, intra- and post-operative data.

排除标准

  • Missing or lacking information in the patients records like preoperative assessment of the fibroid uterus.
  • Absence of operative notes and relevant data in the medical files.

研究组 & 干预措施

Patient who were planned for abdomoinal myomectomy

A retrospective study on women who were candidates for abdominal myomectomy in the previous 4 years

结局指标

主要结局

Incidence of hysterectomy at time of myomectomy.

时间窗: Jan 2020- Dec 2024

次要结局

  • Characteristics of the Myomas who required hysterectomy(Jan 2020- Dec 2024)
  • Intraoperative complications(Jan 2020- Dec 2024)
  • Postoperative complications(Jan 2020- Dec 2024)
  • Duration of hospital stay(Jan 2020- Dec 2024)
  • Reoperation(Jan 2020- Dec 2024)
  • Readmission after discharge from the hospital(Jan 2020- Dec 2024)

研究者

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

Maya Abdelrazek

Lecturer

Ain Shams University

研究点 (1)

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