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Use of Misoprostol in Hysteroscopic Myomectomy

A

Assuta Ashdod Hospital

Status and phase

Not yet enrolling
Phase 4

Conditions

Hysteroscopic Myomectomy

Treatments

Drug: Misoprostol 400 Microgram Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT06049745
0083-23-AAA

Details and patient eligibility

About

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.

Full description

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 .

To the investigators knowledge, the use of misoprostol in hysteroscopic resection has been primarily limited to its role as a cervical dilation primer prior to the procedure. The use of misoprostol in hysteroscopy may reduce the need for mechanical cervical dilatation , however, many centers do not use misoprostol routinely in every hysteroscopy.

Enrollment

200 estimated patients

Sex

Female

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

hysteroscopic myomectomy without misoprostol
No Intervention group
Description:
Patients undergoing hysteroscopic myomectomy that will be randomized to no intervention before the procedure.
Misoprostol group
Experimental group
Description:
Patients undergoing hysteroscopic myomectomy will be randomized to 400 mcg of misoprostol sublingual before the procedure.
Treatment:
Drug: Misoprostol 400 Microgram Oral Tablet

Trial contacts and locations

1

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Central trial contact

oshri barel; alona doron lalehzari

Data sourced from clinicaltrials.gov

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