MyomectomyNCT03250221
Comparison of Robot-assisted Laparoscopic Myomectomy and Traditional Laparoscopic Myomectomy With Barbed Sutures
An observational study of Myomectomy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To elucidate the impact of barbed sutures on robotic myomectomy and laparoscopic myomectomy Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Myomectomy
- What is being tested?
- barbed sutures and Vicryl@ suture
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Mar 2017to 1 Nov 2017
- 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 underwent robotic myomectomy and conventional laparoscopic myomectomy
Who may be able to join
- All women who underwent robotic myomectomy and conventional laparoscopic myomectomy in the Department of Obstetrics \& Gynecology of Far Eastern Memorial Hospital.
Who cannot join
- Open myomectomy
Trial locations and contacts
1 site in 1 country.
About this study
To elucidate the impact of barbed sutures on robotic myomectomy and laparoscopic myomectomy
Read the detailed description
The aim of our study will be to elucidate the impact of the use of barbed sutures on robotic myomectomy and laparoscopic myomectomy
- Conditions
- Myomectomy
- Being tested
- barbed sutures, Vicryl@ suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
barbed suturesDevice
Also called V-Loc
Use of the barbed sutures for robotic or laparoscopic myomectomy
Vicryl@ sutureDevice
Use of Vicryl@ suture for robotic or laparoscopic myomectomy
| Study group | Role | What they receive |
|---|---|---|
| Robotic or laparoscopic myomectomy | Women who received robotic or laparoscopic myomectomy Receives: Device: barbed sutures; Device: Vicryl@ suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal drainage amount
Postoperative day 1 abdominal drainage amount
Measured: 1 day
Secondary outcomes (2)
Blood loss
Blood loss during surgeries
Measured: 1 day
Surgical time
Surgical time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start3 Mar 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
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
- Investigators
- Sheng-Mou Hsiao, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250221
- Sponsor's protocol ID
- 106024-E
- Status last verified
- Feb 2019
- First submitted
- 10 Aug 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsiao SM, Lin HH, Peng FS, Jen PJ, Hsiao CF, Tu FC. Comparison of robot-assisted laparoscopic myomectomy and traditional laparoscopic myomectomy. J Obstet Gynaecol Res. 2013 May;39(5):1024-9. doi: 10.1111/j.1447-0756.2012.02073.x. Epub 2013 Feb 4.
PubMed 23379670
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Robot-assisted Laparoscopic Myomectomy and Traditional Laparoscopic Myomectomy With Barbed Sutures
- ClinicalTrials.gov ID
- NCT03250221
- Acronym / sponsor ID
- 106024-E
- Conditions
- Myomectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 15 Aug 2017 (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 elucidate the impact of barbed sutures on robotic myomectomy and laparoscopic myomectomy
Detailed description
The aim of our study will be to elucidate the impact of the use of barbed sutures on robotic myomectomy and laparoscopic myomectomy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic or laparoscopic myomectomy | – | Device: barbed sutures, Device: Vicryl@ sutureWomen who received robotic or laparoscopic 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 underwent robotic myomectomy and conventional laparoscopic myomectomy
Key inclusion criteria (1 listed)
- All women who underwent robotic myomectomy and conventional laparoscopic myomectomy in the Department of Obstetrics \& Gynecology of Far Eastern Memorial Hospital.
Key exclusion criteria (1 listed)
- Open myomectomy
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 |
|---|---|---|
| barbed suturesAlso: V-LocUse of the barbed sutures for robotic or laparoscopic myomectomy | Device | Robotic or laparoscopic myomectomy |
| Vicryl@ sutureUse of Vicryl@ suture for robotic or laparoscopic myomectomy | Device | Robotic or laparoscopic myomectomy |
Primary outcome
Abdominal drainage amount
Time frame: 1 day
Postoperative day 1 abdominal drainage amount
2 secondary outcomes
Blood loss
Time frame: 1 day
Surgical time
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Background: PubMed 23379670Hsiao SM, Lin HH, Peng FS, Jen PJ, Hsiao CF, Tu FC. Comparison of robot-assisted laparoscopic myomectomy and traditional laparoscopic myomectomy. J Obstet Gynaecol Res. 2013 May;39(5):1024-9. doi: 10.1111/j.1447-0756.2012.02073.x. Epub 2013 Feb 4.
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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.
Sheng-Mou Hsiao, MD principal investigator
Far Eastern Memorial Hospital
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 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 1 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: finished, as of the sponsor's last update on 12 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal drainage amount (time frame: 1 day). 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 NCT03250221, which also lists 1 linked publication.
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 12 Feb 2019.