Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06049745

Use of Misoprostol in Hysteroscopic Myomectomy

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Assuta Ashdod University Hospital

Ashdod, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol 400 Microgram Oral Tablet

Drug

S.L misoprostol 400 mcg

Primary outcomes

  1. length of the procedure

    Time frame: from the first insertion of the hysteroscope to the end of the procedure, minutes

    overall procedure time

Secondary outcomes

  1. fluid absorption

    Time frame: from the start of the procedure to the end of the procedure

    fluid deficit as measured within the procedure

  2. success in one procedure

    Time frame: from the start of the procedure to the end of the procedure

    complete removal of the fibroid in a one step procedure

  3. surgical complications

    Time frame: 1 month folowing the procedure

    surgical complications according to the Dindo-Clavien scale

  4. patient satisfaction

    Time frame: within 30 days of the procedure

    satisfaction from the procedure on a scale of 1-10

  5. blood loss

    Time frame: from the start of the procedure until the patient has left the operating room

    estimated blood loss as measured by the surgeon during the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

alona doron lalehzari

CONTACT

[email protected]

972 50 880 7991

oshri barel

CONTACT

[email protected]

972 55 938 2117

Sponsors and collaborators

Lead sponsor

Assuta Ashdod Hospital

Other

Collaborators

  • Assuta Medical Center

Registry information

Official study title

Use of Misoprostol in Hysteroscopic Myomectomy, a Randomized Peospective Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.