Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06049745
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-22
First Post:
2023-08-29
Brief Title:
Use of Misoprostol in Hysteroscopic Myomectomy
Sponsor:
Assuta Ashdod Hospital
Organization:
Assuta Ashdod Hospital
Study Overview
Official Title:
Use of Misoprostol in Hysteroscopic Myomectomy a Randomized Peospective Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None