Use of Misoprostol in Hysteroscopic Myomectomy
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| ClinicalTrials.gov Identifier: NCT06049745 |
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Recruitment Status :
Not yet recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hysteroscopic Myomectomy | Drug: Misoprostol 400 Microgram Oral Tablet | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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) |
| Primary Purpose: | Treatment |
| Official Title: | Use of Misoprostol in Hysteroscopic Myomectomy, a Randomized Peospective Trial |
| Estimated Study Start Date : | November 2023 |
| Estimated Primary Completion Date : | August 2026 |
| Estimated Study Completion Date : | October 2026 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: hysteroscopic myomectomy without misoprostol
Patients undergoing hysteroscopic myomectomy that will be randomized to no intervention before the procedure.
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Experimental: Misoprostol group
Patients undergoing hysteroscopic myomectomy will be randomized to 400 mcg of misoprostol sublingual before the procedure.
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Drug: Misoprostol 400 Microgram Oral Tablet
S.L misoprostol 400 mcg |
- length of the procedure [ Time Frame: from the first insertion of the hysteroscope to the end of the procedure, minutes ]overall procedure time
- fluid absorption [ Time Frame: from the start of the procedure to the end of the procedure ]fluid deficit as measured within the procedure
- 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
- surgical complications [ Time Frame: 1 month folowing the procedure ]surgical complications according to the Dindo-Clavien scale
- patient satisfaction [ Time Frame: within 30 days of the procedure ]satisfaction from the procedure on a scale of 1-10
- 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
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| Ages Eligible for Study: | 20 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049745
| Contact: oshri barel | 972 55 938 2117 | oshrib@assuta.co.il | |
| Contact: alona doron lalehzari | 972 50 880 7991 | alonado@assuta.co.il |
| Israel | |
| Assuta Ashdod University Hospital | |
| Ashdod, Israel | |
| Responsible Party: | Oshri Barell, Head of Gynecology Division, Department of Obstetrics and Gynecology. Assuta Ashdod University Hospital, Assuta Ashdod Hospital |
| ClinicalTrials.gov Identifier: | NCT06049745 |
| Other Study ID Numbers: |
0083-23-AAA |
| First Posted: | September 22, 2023 Key Record Dates |
| Last Update Posted: | September 22, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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hysteroscopic myomectomy misoprostol |
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Misoprostol Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics |