Hysteroscopic MyomectomyNCT05423925
Comparison of Perioperative Outcome Between Monopolar and Bipolar Hysteroscopic Myomectomy
An observational study of Hysteroscopic Myomectomy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Objective: To evaluate clinical outcome between monopolar and bipolar hysteroscopic myomectomy. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Hysteroscopic Myomectomy
- What is being tested?
- Bipolar hysteroscopic myomectomy and Monopolar hysteroscopic myomectomy
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jun 2022to 31 Dec 2023
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: > 20 years old women who received hysteroscopic myomectomy
Who may be able to join
- women who received hysteroscopic myomectomy between July 2008 and April 2022 will be reviewed.
Who cannot join
- < 20 years old women
- Cervical fibroids were excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
Sheng-Mou Hsiao, M.D., +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
Objective:
To evaluate clinical outcome between monopolar and bipolar hysteroscopic myomectomy.
Read the detailed description
Methods:
Hysteoscopic myomectomy is a safe and effective procedure to remove submucosal myoma. Distension media is needed to distend the uterine cavity during the procedure. The electric cutting loops included monopolar and bipolar electrodes, and have their corresponding distension media. Medical records, including outpatient and inpatient records, operation note, and laboratory data, of all consecutive women who received hysteroscopic myomectomy between July 2008 and April 2022 will be reviewed.
Expected result: The investigatorscan get the differences between monopolar and bipolar hysteroscopic myomectomy, and the result can be used as a reference in clinical practice.
- Conditions
- Hysteroscopic Myomectomy
- Being tested
- Bipolar hysteroscopic myomectomy, Monopolar hysteroscopic myomectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar hysteroscopic myomectomyProcedure or surgery
Bipolar hysteroscopic myomectomy.
Monopolar hysteroscopic myomectomyProcedure or surgery
Monopolar hysteroscopic myomectomy
| Study group | Role | What they receive |
|---|---|---|
| monopolar | monopolar electrodes, and have their corresponding distension media. Receives: Procedure: Monopolar hysteroscopic myomectomy | |
| bipolar | bipolar electrodes, and have their corresponding distension media. Receives: Procedure: Bipolar hysteroscopic myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infused volume of distension medium
The differences of infused volume of distension medium
Measured: 3 months
Secondary outcomes (2)
Operation time
The between-group difference in operation time
Measured: 3 months
Pain score after the procedure
The between-group difference in pain score after the procedure Pain score:0-10, the minimun values mean a better
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start7 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423925
- Sponsor's protocol ID
- 111121-E
- Status last verified
- Jul 2023
- First submitted
- 14 Jun 2022
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Outcome Between Monopolar and Bipolar Hysteroscopic Myomectomy
- ClinicalTrials.gov ID
- NCT05423925
- Acronym / sponsor ID
- 111121-E
- Conditions
- Hysteroscopic Myomectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Jun 2022 (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.
Objective:
To evaluate clinical outcome between monopolar and bipolar hysteroscopic myomectomy.
Detailed description
Methods:
Hysteoscopic myomectomy is a safe and effective procedure to remove submucosal myoma. Distension media is needed to distend the uterine cavity during the procedure. The electric cutting loops included monopolar and bipolar electrodes, and have their corresponding distension media. Medical records, including outpatient and inpatient records, operation note, and laboratory data, of all consecutive women who received hysteroscopic myomectomy between July 2008 and April 2022 will be reviewed.
Expected result: The investigatorscan get the differences between monopolar and bipolar hysteroscopic myomectomy, and the result can be used as a reference in clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monopolar | – | Procedure: Monopolar hysteroscopic myomectomymonopolar electrodes, and have their corresponding distension media. |
| bipolar | – | Procedure: Bipolar hysteroscopic myomectomybipolar electrodes, and have their corresponding distension media. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- > 20 years old women who received hysteroscopic myomectomy
Key inclusion criteria (1 listed)
- women who received hysteroscopic myomectomy between July 2008 and April 2022 will be reviewed.
Key exclusion criteria (2 listed)
- < 20 years old women
- Cervical fibroids were excluded.
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 |
|---|---|---|
| Bipolar hysteroscopic myomectomyBipolar hysteroscopic myomectomy. | Procedure or surgery | bipolar |
| Monopolar hysteroscopic myomectomyMonopolar hysteroscopic myomectomy | Procedure or surgery | monopolar |
Primary outcome
Infused volume of distension medium
Time frame: 3 months
The differences of infused volume of distension medium
2 secondary outcomes
Operation time
Time frame: 3 months
Pain score after the procedure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- 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.
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysteroscopic Myomectomy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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 10 Jul 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 Taiwan. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infused volume of distension medium (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.