Women With Uterine MyomaNCT06208891
Clinical Outcomes of Robotic Myomectomy
An observational study of Women With Uterine Myoma, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To identify the predictors of perioperative outcomes in women who receive robotic myomectomy Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Women With Uterine Myoma
- What is being tested?
- Robotic myomectomy
- Type of treatment
- Surgery or procedure
- How many people
- 400 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: Women who received robotic-assisted myomectomy
Who may be able to join
- >20 years old women
- women who received robotic 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: Clinical Outcomes of Robotic Myomectomy: Comparisons of Without Versus With Temporary or Permanent Uterine Artery Occlusion.
To identify the predictors of perioperative outcomes in women who receive robotic myomectomy
Read the detailed description
Uterine myoma is the most common gynecological tumor. Current surgical management was inclusive of conventional abdominal myomectomy, laparoscopy-assisted myomectomy, robotic-assisted myomectomy. The aim of this study was to identify the predictors of perioperative outcomes in women who receive robotic myomectomy
- Conditions
- Women With Uterine Myoma
- Being tested
- Robotic myomectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic myomectomyProcedure or surgery
Robotic assisted laparoscopic myomectomy
| Study group | Role | What they receive |
|---|---|---|
| Robotic myomectomy | Women who received robotic myomectomy Receives: Procedure: Robotic myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical time
Factors (e.g., the location and largest diameter of the uterine myoma) predicting surgical time
Measured: 1 week
Secondary outcomes (1)
Intraoperative blood loss
Factors (e.g., the location and largest diameter of the uterine myoma) predicting intraoperative blood loss
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 posted17 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 Women With Uterine MyomaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 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
- NCT06208891
- Sponsor's protocol ID
- 112185-E
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 17 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Robotic Myomectomy: Comparisons of Without Versus With Temporary or Permanent Uterine Artery Occlusion.
- ClinicalTrials.gov ID
- NCT06208891
- Acronym / sponsor ID
- 112185-E
- Conditions
- Women With Uterine Myoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 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
- 17 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 identify the predictors of perioperative outcomes in women who receive robotic myomectomy
Detailed description
Uterine myoma is the most common gynecological tumor. Current surgical management was inclusive of conventional abdominal myomectomy, laparoscopy-assisted myomectomy, robotic-assisted myomectomy. The aim of this study was to identify the predictors of perioperative outcomes in women who receive robotic myomectomy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic myomectomy | – | Procedure: Robotic myomectomyWomen who received robotic myomectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who received robotic-assisted myomectomy
Key inclusion criteria (2 listed)
- >20 years old women
- women who received robotic 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 |
|---|---|---|
| Robotic myomectomyRobotic assisted laparoscopic myomectomy | Procedure or surgery | Robotic myomectomy |
Primary outcome
Surgical time
Time frame: 1 week
Factors (e.g., the location and largest diameter of the uterine myoma) predicting surgical time
1 secondary outcome
Intraoperative blood loss
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 17 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 Women With Uterine Myoma, 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 17 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?
Surgical time (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 17 Jan 2024.