Hysteroscopic MyomectomyNCT06195826
Gravity Versus Pump Infusion of Distending Media for Hysteroscopic Myomectomy
An observational study of Hysteroscopic Myomectomy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To compare the perioperative outcome between the gravity versus pump infusion groups in women who received 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?
- Gravity infusion and Pump infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Nov 2023to 31 Dec 2024
- 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: Patients who received hysteroscopic myomectomy
Who may be able to join
- >20 years old women
- women who received hysteroscopic myomectomy
Who cannot join
None listed.
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
Official title: Gravity Versus Pump Infusion of Distending Media for Hysteroscopic Myomectomy: A Retrospective Cohort Study
To compare the perioperative outcome between the gravity versus pump infusion groups in women who received hysteroscopic myomectomy
- Conditions
- Hysteroscopic Myomectomy
- Being tested
- Gravity infusion, Pump infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gravity infusionProcedure or surgery
hysteroscopic myomectomy with the gravity infusion method
Pump infusionProcedure or surgery
hysteroscopic myomectomy with the pump infusion method
| Study group | Role | What they receive |
|---|---|---|
| gravity infusion | women who received hysteroscopic myomectomy with gravity infusion method Receives: Procedure: Gravity infusion | |
| pump infusion | women who received hysteroscopic myomectomy with pump infusion method Receives: Procedure: Pump infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infusion volume of distension medium
Infusion volume (mL) of distension medium in the uterine cavity between the gravity and pump infusion methods for hysterosopic myomectomy
Measured: 1 week
Secondary outcomes (3)
Intraoperative blood loss
Intraoperative blood loss (mL) between the gravity and pump infusion methods for hysterosopic myomectomy
Measured: 1 week
Postoperative pain
Postoperative pain (visual analogue scale 0-10) in the recovery room between the gravity versus pump infusion methods for hysterosopic myomectomy.
Measured: 1 week
Surgical time
Surgical time (minutes) between the gravity versus pump infusion methods for hysterosopic myomectomy
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start21 Nov 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- 100 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
- NCT06195826
- Sponsor's protocol ID
- 112180-E
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gravity Versus Pump Infusion of Distending Media for Hysteroscopic Myomectomy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06195826
- Acronym / sponsor ID
- 112180-E
- Conditions
- Hysteroscopic Myomectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jan 2024 (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.
To compare the perioperative outcome between the gravity versus pump infusion groups in women who received hysteroscopic myomectomy
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gravity infusion | – | Procedure: Gravity infusionwomen who received hysteroscopic myomectomy with gravity infusion method |
| pump infusion | – | Procedure: Pump infusionwomen who received hysteroscopic myomectomy with pump infusion method |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received hysteroscopic myomectomy
Key inclusion criteria (2 listed)
- >20 years old women
- women who received hysteroscopic myomectomy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Gravity infusionhysteroscopic myomectomy with the gravity infusion method | Procedure or surgery | gravity infusion |
| Pump infusionhysteroscopic myomectomy with the pump infusion method | Procedure or surgery | pump infusion |
Primary outcome
Infusion volume of distension medium
Time frame: 1 week
Infusion volume (mL) of distension medium in the uterine cavity between the gravity and pump infusion methods for hysterosopic myomectomy
3 secondary outcomes
Intraoperative blood loss
Time frame: 1 week
Postoperative pain
Time frame: 1 week
Surgical time
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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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 2 inclusion and 0 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 8 Jan 2024. 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?
Infusion volume of distension medium (time frame: 1 week). 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 8 Jan 2024.