Clinical trial NCT06049745: Use of Misoprostol in Hysteroscopic Myomectomy
Official title: Use of Misoprostol in Hysteroscopic Myomectomy, a Randomized Peospective Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hysteroscopic Myomectomy
Keywords: hysteroscopic myomectomy
misoprostol
Lead sponsor: Assuta Ashdod Hospital
Sponsor class: OTHER
Collaborators: name: Assuta Medical Center
First posted: 2023-09-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: length of the procedure
timeFrame: from the first insertion of the hysteroscope to the end of the procedure, minutes
Secondary outcomes:
measure: fluid absorption
timeFrame: from the start of the procedure to the end of the procedure
measure: success in one procedure
timeFrame: from the start of the procedure to the end of the procedure
measure: surgical complications
timeFrame: 1 month folowing the procedure
measure: patient satisfaction
timeFrame: within 30 days of the procedure
measure: blood loss
timeFrame: from the start of the procedure until the patient has left the operating room
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Assuta Ashdod University Hospital
Study officials:
References:
citation: Moawad NS, Palin H. Hysteroscopic Myomectomy. Obstet Gynecol Clin North Am. 2022 Jun;49(2):329-353. doi: 10.1016/j.ogc.2022.02.012.
citation: Loddo A, Djokovic D, Drizi A, De Vree BP, Sedrati A, van Herendael BJ. Hysteroscopic myomectomy: The guidelines of the International Society for Gynecologic Endoscopy (ISGE). Eur J Obstet Gynecol Reprod Biol. 2022 Jan;268:121-128. doi: 10.1016/j.ejogrb.2021.11.434. Epub 2021 Dec 1.
citation: Zayed M, Fouda UM, Zayed SM, Elsetohy KA, Hashem AT. Hysteroscopic Myomectomy of Large Submucous Myomas in a 1-Step Procedure Using Multiple Slicing Sessions Technique. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1196-202. doi: 10.1016/j.jmig.2015.06.008. Epub 2015 Jun 18.
citation: Indraccolo U, Bini V, Favilli A. Likelihood of Accomplishing an In-Patient Hysteroscopic Myomectomy in a One-Step Procedure: A Systematic Review and Meta-Analysis. Biomed Res Int. 2020 Jan 8;2020:4208497. doi: 10.1155/2020/4208497. eCollection 2020.
citation: Umranikar S, Clark TJ, Saridogan E, Miligkos D, Arambage K, Torbe E, Campo R, Di Spiezio Sardo A, Tanos V, Grimbizis G; British Society for Gynaecological Endoscopy /European Society for Gynaecological Endoscopy Guideline Development Group for Management of Fluid Distension Media in Operative Hysteroscopy. BSGE/ESGE guideline on management of fluid distension media in operative hysteroscopy. Gynecol Surg. 2016;13(4):289-303. doi: 10.1007/s10397-016-0983-z. Epub 2016 Oct 6. No abstract available.
citation: Murakami T, Shimizu T, Katahira A, Terada Y, Yokomizo R, Sawada R. Intraoperative injection of prostaglandin F2alpha in a patient undergoing hysteroscopic myomectomy. Fertil Steril. 2003 Jun;79(6):1439-41. doi: 10.1016/s0015-0282(03)00386-8.
citation: Indman PD. Use of carboprost to facilitate hysteroscopic resection of submucous myomas. J Am Assoc Gynecol Laparosc. 2004 Feb;11(1):68-72. doi: 10.1016/s1074-3804(05)60014-x.
citation: Al-Fozan H, Firwana B, Al Kadri H, Hassan S, Tulandi T. Preoperative ripening of the cervix before operative hysteroscopy. Cochrane Database Syst Rev. 2015 Apr 23;2015(4):CD005998. doi: 10.1002/14651858.CD005998.pub2.
citation: Lasmar RB, Lasmar BP, Celeste RK, da Rosa DB, Depes Dde B, Lopes RG. A new system to classify submucous myomas: a Brazilian multicenter study. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):575-80. doi: 10.1016/j.jmig.2012.03.026. Epub 2012 Jul 20.