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Clinical Trials/NCT07365969
NCT07365969
Completed
Not Applicable

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

Ain Shams University1 site in 1 country293 target enrollmentStarted: December 15, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
293
Locations
1
Primary Endpoint
Incidence of hysterectomy at time of myomectomy.

Overview

Brief Summary

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.

Detailed Description

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).

Hysterectomy is the most performed surgical treatment for myoma-related symptoms, whereas myomas are also the leading indication for surgery in women of the reproductive age (Stewart et al., 2016; Laughlin-Tommaso et al., 2020). It is associated with significant morbidity, mortality, and economic burden on the health care system (Clark-Pearson and Geller.,2 013).

Although hysterectomy provides definitive treatment for symptomatic women, it may not be a viable option for young women and those who desire fertility preservation, alternatives must be considered. Uterine preservation options are becoming increasingly important. The most common non-pharmacologic solution for women who desire future childbearing is a myomectomy (Laughlin-Tommaso., 2016).

Although quality of life (QoL) after myomectomy is adequately studied and indicates a significant improvement after both short- and long-term follow-up (Hartmann et., al 2017; Daniels et al., 2022).

Several studies that have surveyed women on their attitudes about hysterectomy versus uterine sparing procedures demonstrated that a significant portion of patients wish to preserve the uterus for personal identity, culture, and religious considerations. Uterine preservation has also been shown to have better outcomes regarding self-esteem, sexuality and body image compared to hysterectomy (Wilson, 2018).

The hypothesis of this study is that analysis of the data of the patients with myomas that required hysterectomy at time of myomectomy could help in counselling of patients regarding the risks during surgery especially for young patient desire fertility.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Arms & Interventions

Patient who were planned for abdomoinal myomectomy

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

Outcomes

Primary Outcomes

Incidence of hysterectomy at time of myomectomy.

Time Frame: Jan 2020- Dec 2024

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maya Abdelrazek

Lecturer

Ain Shams University

Study Sites (1)

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