Hysteroscopic MyomectomyPhase 4NCT06049745
Use of Misoprostol in Hysteroscopic Myomectomy
A Phase 4 study testing Misoprostol 400 Microgram Oral Tablet in people with Hysteroscopic Myomectomy, run by Assuta Ashdod Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysteroscopic Myomectomy
- What is being tested?
- Misoprostol 400 Microgram Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2023to Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Misoprostol in Hysteroscopic Myomectomy, a Randomized Peospective Trial
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.
Read the 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.
- Conditions
- Hysteroscopic Myomectomy
- Being tested
- Misoprostol 400 Microgram Oral Tablet
- Keywords
- hysteroscopic myomectomy, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 400 Microgram Oral TabletDrug
S.L misoprostol 400 mcg
| Study group | Role | What they receive |
|---|---|---|
| hysteroscopic myomectomy without misoprostol | No intervention | Patients undergoing hysteroscopic myomectomy that will be randomized to no intervention before the procedure. |
| Misoprostol group | Experimental | Patients undergoing hysteroscopic myomectomy will be randomized to 400 mcg of misoprostol sublingual before the procedure. Receives: Drug: Misoprostol 400 Microgram Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of the procedure
overall procedure time
Measured: from the first insertion of the hysteroscope to the end of the procedure, minutes
Secondary outcomes (5)
fluid absorption
fluid deficit as measured within the procedure
Measured: 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
Measured: from the start of the procedure to the end of the procedure
surgical complications
surgical complications according to the Dindo-Clavien scale
Measured: 1 month folowing the procedure
patient satisfaction
satisfaction from the procedure on a scale of 1-10
Measured: within 30 days of the procedure
blood loss
estimated blood loss as measured by the surgeon during the procedure
Measured: from the start of the procedure until the patient has left the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study startNov 2023 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hysteroscopic MyomectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Ashdod Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Assuta Medical Center
- Responsible party
- Principal investigator, Oshri Barell, Assuta Ashdod Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049745
- Sponsor's protocol ID
- 0083-23-AAA
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35636812Loddo 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.
PubMed 34902749Zayed 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.
PubMed 26093183Indraccolo 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.
PubMed 32090092Umranikar 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.
PubMed 28003797Murakami 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.
PubMed 12798895Indman 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.
PubMed 15104835Al-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.
PubMed 25906113Lasmar 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.
PubMed 22819007
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Misoprostol in Hysteroscopic Myomectomy, a Randomized Peospective Trial
- ClinicalTrials.gov ID
- NCT06049745
- Acronym / sponsor ID
- 0083-23-AAA
- Conditions
- Hysteroscopic Myomectomy
- Keywords
- hysteroscopic myomectomy, misoprostol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assuta Ashdod HospitalUniversity, hospital or other
- Collaborators
- Assuta Medical Center
- Study start
- Nov 2023 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| hysteroscopic myomectomy without misoprostol | No intervention | –Patients undergoing hysteroscopic myomectomy that will be randomized to no intervention before the procedure. |
| Misoprostol group | Experimental | Drug: Misoprostol 400 Microgram Oral TabletPatients undergoing hysteroscopic myomectomy will be randomized to 400 mcg of misoprostol sublingual before the procedure. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol 400 Microgram Oral TabletS.L misoprostol 400 mcg | Drug | Misoprostol group |
Primary outcome
length of the procedure
Time frame: from the first insertion of the hysteroscope to the end of the procedure, minutes
overall procedure time
5 secondary outcomes
fluid absorption
Time frame: from the start of the procedure to the end of the procedure
success in one procedure
Time frame: from the start of the procedure to the end of the procedure
surgical complications
Time frame: 1 month folowing the procedure
patient satisfaction
Time frame: within 30 days of the procedure
blood loss
Time frame: from the start of the procedure until the patient has left the operating room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 35636812Moawad NS, Palin H. Hysteroscopic Myomectomy. Obstet Gynecol Clin North Am. 2022 Jun;49(2):329-353. doi: 10.1016/j.ogc.2022.02.012.
- Background: PubMed 34902749Loddo 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.
- Background: PubMed 26093183Zayed 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.
- Background: PubMed 32090092Indraccolo 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.
- Background: PubMed 28003797Umranikar 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.
- Background: PubMed 12798895Murakami 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.
- Background: PubMed 15104835Indman 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.
- Background: PubMed 25906113Al-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.
- Background: PubMed 22819007Lasmar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol 400 Microgram Oral Tablet in people with Hysteroscopic Myomectomy, run by Assuta Ashdod Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact oshri barel (972 55 938 2117, oshrib@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of the procedure (time frame: from the first insertion of the hysteroscope to the end of the procedure, minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049745, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.