Uterine MyomaPhase 3NCT01984632
Barbed Suture in Single-port Laparoscopic Myomectomy
A Phase 3 study testing Single-port laparoscopic myomectomy and Multi-port laparoscopic myomectomy in people with Uterine Myoma, run by CHA University at 4 sites in South Korea.
Trial summary
The aim of this study is to test our hypothesis that the use of unidirectional knotless barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine wall defect after myoma enucleation as multi-port laparoscopic myomectomy did. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Uterine Myoma
- What is being tested?
- Single-port laparoscopic myomectomy and Multi-port laparoscopic myomectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Nov 2013to Dec 2014
- Phase
- Phase 3
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 55 years
- Image-confirmed uterine myoma
- Number of myoma ≤2 and largest size ≤10cm
- Women who were scheduled to have laparoscopic myomectomy
- Appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)
Who cannot join
- Women with pedunculated subserosal myoma or submucosal myoma
- Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis
- Women with any suggestion of malignant uterine or adnexal diseases
- Women with diabetics, malignancy, or malnutrition, which can affect wound healing
- Women having major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
- Women who refuse to participate or give consent to the procedures
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
National Health Insurance Service Ilsan Hospital
Goyang
CHA Gangnam Medical Center
Seoul
Kangbuk Samsung Hospital
Seoul
Samsung Medical Center
Seoul
About this study
Official title: Single-port Laparoscopic Myomectomy Using Barbed Suture Versus Multi-port One: a Multi-center Randomized Controlled Trial
The aim of this study is to test our hypothesis that the use of unidirectional knotless barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.
Read the detailed description
The investigators plan to perform a multi-center randomized clinical trial on women scheduled for laparoscopic myomectomy. All women will get the same preoperative and postoperative care. Women will be assigned by chance to one of two groups: one group will receive single-port laparoscopic myomectomy using V-Loc™ suture material (study group). The other group will receive conventional multi-port laparoscopic myomectomy using V-Loc™ suture material (control group). The investigators will collect information on suturing time and complications related to surgery.
- Conditions
- Uterine Myoma
- Being tested
- Single-port laparoscopic myomectomy, Multi-port laparoscopic myomectomy
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-port laparoscopic myomectomyProcedure or surgery
The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture (control group) in terms of operative time (esp. suturing time).
Multi-port laparoscopic myomectomyProcedure or surgery
The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture(control group) in terms of operative time (esp. suturing time).
| Study group | Role | What they receive |
|---|---|---|
| Single-port laparoscopic myomectomy | Experimental | We will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy Receives: Procedure: Single-port laparoscopic myomectomy |
| Multi-port laparoscopic myomectomy | Active comparator | We will use barbed suture(V-Loc) under intervention of multi-port laparoscopic myomectomy. Receives: Procedure: Multi-port laparoscopic myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suturing time
the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy
Measured: Intra-operative
Secondary outcomes (1)
Cosmetic satisfaction
We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire).
Measured: Post-surgery 1 month and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
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 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taejong Song, CHA University
- Investigators
- Taejong Song, MD, Principal investigator, CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984632
- Sponsor's protocol ID
- MYO04
- Status last verified
- Jul 2015
- First submitted
- 3 Nov 2013
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Song T, Kim TJ, Lee SH, Kim TH, Kim WY. Laparoendoscopic single-site myomectomy compared with conventional laparoscopic myomectomy: a multicenter, randomized, controlled trial. Fertil Steril. 2015 Nov;104(5):1325-31. doi: 10.1016/j.fertnstert.2015.07.1137. Epub 2015 Aug 8.
PubMed 26263079
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-port Laparoscopic Myomectomy Using Barbed Suture Versus Multi-port One: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01984632
- Acronym / sponsor ID
- MYO04
- Conditions
- Uterine Myoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Nov 2013 (estimated)
- 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.
The aim of this study is to test our hypothesis that the use of unidirectional knotless barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.
Detailed description
The investigators plan to perform a multi-center randomized clinical trial on women scheduled for laparoscopic myomectomy. All women will get the same preoperative and postoperative care. Women will be assigned by chance to one of two groups: one group will receive single-port laparoscopic myomectomy using V-Loc™ suture material (study group). The other group will receive conventional multi-port laparoscopic myomectomy using V-Loc™ suture material (control group). The investigators will collect information on suturing time and complications related to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-port laparoscopic myomectomy | Experimental | Procedure: Single-port laparoscopic myomectomyWe will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy |
| Multi-port laparoscopic myomectomy | Active comparator | Procedure: Multi-port laparoscopic myomectomyWe will use barbed suture(V-Loc) under intervention of multi-port laparoscopic myomectomy. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 55 years
- Image-confirmed uterine myoma
- Number of myoma ≤2 and largest size ≤10cm
- Women who were scheduled to have laparoscopic myomectomy
- Appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)
Key exclusion criteria (6 listed)
- Women with pedunculated subserosal myoma or submucosal myoma
- Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis
- Women with any suggestion of malignant uterine or adnexal diseases
- Women with diabetics, malignancy, or malnutrition, which can affect wound healing
- Women having major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
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 |
|---|---|---|
| Single-port laparoscopic myomectomyThe aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture (control group) in terms of operative time (esp. suturing time). | Procedure or surgery | Single-port laparoscopic myomectomy |
| Multi-port laparoscopic myomectomyThe aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture(control group) in terms of operative time (esp. suturing time). | Procedure or surgery | Multi-port laparoscopic myomectomy |
Primary outcome
Suturing time
Time frame: Intra-operative
the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy
1 secondary outcome
Cosmetic satisfaction
Time frame: Post-surgery 1 month and 3 month
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 31 Jul 2015.
- Derived from this study: PubMed 26263079Song T, Kim TJ, Lee SH, Kim TH, Kim WY. Laparoendoscopic single-site myomectomy compared with conventional laparoscopic myomectomy: a multicenter, randomized, controlled trial. Fertil Steril. 2015 Nov;104(5):1325-31. doi: 10.1016/j.fertnstert.2015.07.1137. Epub 2015 Aug 8.
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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.
Taejong Song, MD principal investigator
CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Single-port laparoscopic myomectomy and Multi-port laparoscopic myomectomy in people with Uterine Myoma, run by CHA University at 4 sites in South Korea.
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 6 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 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Suturing time (time frame: Intra-operative). 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 NCT01984632, 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 31 Jul 2015; AzTrials last refreshed its copy on 1 Nov 2026.