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临床试验/NCT06049745
NCT06049745尚未招募4 期

Use of Misoprostol in Hysteroscopic Myomectomy, a Randomized Peospective Trial

Assuta Ashdod Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
length of the procedure

研究概览

简要总结

Hysteroscopic myomectomy is typically suitable for myomas measuring under 4 cm in size. The utilization of misoprostol before the procedure can facilitate uterine access, decrease fluid absorption, and reduce blood loss, consequently leading to a decrease in the overall procedure time. In this randomized trial, the investigators aim to investigate the impact of misoprostol administration and its effects on each of the mentioned parameters.

详细描述

Hysteroscopic myomectomy is a minimally invasive surgical procedure designed to remove uterine fibroids that are located within the uterine cavity. Traditionally, hysteroscopic myomectomy for large fibroids has been performed as a two-step procedure, with fibroid removal divided into separate stages. However, advancements in surgical techniques and equipment have allowed for the development of hysteroscopic myomectomy as a one-step procedure, in which all fibroids are removed in a single surgical session.

As a one-step procedure, hysteroscopic myomectomy offers several potential benefits. It eliminates the need for multiple surgeries and reduces the overall treatment timeline for patients. The size limit for hysteroscopic myomectomy varies among surgeons and institutions. In general, submucosal fibroids up to 4 centimeters in diameter are considered suitable for hysteroscopic resection.

Fluid overload is an important consideration in hysteroscopic myomectomy, especially when it is performed as a one-step procedure, making it a time-limited procedure. During hysteroscopic myomectomy, a distension media is used to expand the uterine cavity, providing better visualization and creating a working space for the surgeon. However, there is a risk of fluid overload if excessive fluid is absorbed into the bloodstream, potentially leading to complications such as electrolyte imbalances, fluid imbalance, hyponatremia, or cardiovascular issues. To mitigate this risk, certain precautions are taken during the procedure.

When the uterus contracts, the fibroid may undergo several changes. These changes can affect the position, size, and accessibility of the fibroid, potentially influencing the surgical approach and outcome. Fibroid extrusion occurs when the fibroid becomes detached from its attachment site and is pushed out of the uterus by the uterine contractions.

A case study published by Murakami et al. discussed the contributing effect of intraoperative injection of prostaglandin F2 alpha in a patient undergoing hysteroscopic myomectomy, resulting in a successful one-step hysteroresectoscopy of a sessile submucous leiomyoma . Additionally, Indman described the effect of intracervical injection of carboprost prior to hysteroscopic resection of submucous myomas that could not be completely resected in a series of 10 case studies .

研究设计

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

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women between the ags of 20 years- 55 years, inclusive
  • undergoing hysteroscopic myomectomy
  • submucosal fibroid less than 40 mm (type 0, 1 and 2)
  • up to 2 submucosal fibroids
  • patients are able to provide written informed consent

排除标准

  • post menopausal women
  • inability to perform operative hysteroscopy under anesthesia in the past due to cervical stenosis
  • previous PID or documented tubal occlusion
  • positive BHCG test
  • inability to consent due to cognitive or language barrier
  • allergy to misoprostole
  • severe COPD, asthma or cardiac disease

研究组 & 干预措施

Misoprostol group

Experimental

Patients undergoing hysteroscopic myomectomy will be randomized to 400 mcg of misoprostol sublingual before the procedure.

干预措施: Misoprostol 400 Microgram Oral Tablet (Drug)

结局指标

主要结局

length of the procedure

时间窗: from the first insertion of the hysteroscope to the end of the procedure, minutes

overall procedure time

次要结局

  • surgical complications(1 month folowing the procedure)
  • fluid absorption(from the start of the procedure to the end of the procedure)
  • patient satisfaction(within 30 days of the procedure)
  • blood loss(from the start of the procedure until the patient has left the operating room)
  • success in one procedure(from the start of the procedure to the end of the procedure)

研究者

发起方
Assuta Ashdod Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oshri Barell

Head of Gynecology Division, Department of Obstetrics and Gynecology. Assuta Ashdod University Hospital

Assuta Ashdod Hospital

研究点 (1)

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