Use of Misoprostol in Hysteroscopic Myomectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of Misoprostol in Hysteroscopic Myomectomy, a Randomized Peospective Trial

Conditions
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Hysteroscopic Myomectomy

Intervention / Treatment
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* Drug: Misoprostol 400 Microgram Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients undergoing hysteroscopic myomectomy will be divided into two groups, the study group will receive misoprostol before the procedure. the control group will not receive treatment with misoprostol.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: hysteroscopic myomectomy without misoprostol<br>Patients undergoing hysteroscopic myomectomy that will be randomized to no intervention before the procedure. | |
| Experimental: Misoprostol group<br>Patients undergoing hysteroscopic myomectomy will be randomized to 400 mcg of misoprostol sublingual before the procedure. | Drug: Misoprostol 400 Microgram Oral Tablet<br>* S.L misoprostol 400 mcg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of the procedure | overall procedure time | from the first insertion of the hysteroscope to the end of the procedure, minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid absorption | fluid deficit as measured within the procedure | from the start of the procedure to the end of the procedure | 
| success in one procedure | complete removal of the fibroid in a one step procedure | from the start of the procedure to the end of the procedure | 
| surgical complications | surgical complications according to the Dindo-Clavien scale | 1 month folowing the procedure | 
| patient satisfaction | satisfaction from the procedure on a scale of 1-10 | within 30 days of the procedure | 
| blood loss | estimated blood loss as measured by the surgeon during the procedure | from the start of the procedure until the patient has left the operating room | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysteroscopic myomectomy, misoprostol