Cosmetic OutcomesSMNCT01826578
Single Port Myomectomy Versus Conventional Myomectomy
A study testing using only one port for laparoscopic surgery in people with Cosmetic Outcomes, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is about the evaluation of which benefits single port laparoscopic myomectomy has in the perspective of cosmetics and patient satisfaction. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cosmetic Outcomes
- What is being tested?
- using only one port for laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Dec 2014
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- premenopausal women
- image confirmed myoma
- scheduled to have laparoscopic myomectomy
- number of myoma =<4 and largest size <10cm
Who cannot join
- scheduled to have co-operation of other surgery
- clinically significant hematologic abnormality
- DM or malnutrition
- under the medication which can affect wound healing
- previous history of other pelvic surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul University Bundang Hospital OB & GY
Sungnam-si, Kyeonggi-do, 463-707
About this study
Official title: Prospective Randomized Controlled Trial to Analyze the Benefits of Single Port Laparoscopic Myomectomy in the View of Cosmetics and Patient Satisfaction
This study is about the evaluation of which benefits single port laparoscopic myomectomy has in the perspective of cosmetics and patient satisfaction.
Read the detailed description
There were several studies about feasibility and cosmetic benefit of single port laparoscopic adnexal surgery and hysterectomy compared to conventional multiport laparoscopic surgery. Meanwhile, no study mentioned benefit of single port laparoscopic surgery in myomectomy because single port myomectomy needs more labor and operator's skill than other pelvic surgery. At this point, the investigators need to verify the effectiveness and benefit of single port laparoscopic myomectomy.
- Conditions
- Cosmetic Outcomes
- Being tested
- using only one port for laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using only one port for laparoscopic surgeryProcedure or surgery
Also called Single port intervention
using only one port for laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| single port arm | Experimental | Not described Receives: Procedure: using only one port for laparoscopic surgery |
| Conventional arm | No intervention | Using 3-4 port for laparosocpic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of scar evaluation
The characteristics of scar such as color, pliability, and stiffness are willing to be measured in 1 week and 8 week later after myomectomy. The level of satisfaction of patients will also be evaluated.
Measured: for 8 weeks
Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of patient satisfaction
Patient satisfaction about scar formation after myomectomy are willing to be evaluated after surgery.
Measured: for 8 weeks
Secondary outcomes (1)
General composite characteristics of surgery procedure and outcome
Composite parameters about surgery outcome and complication such as Op time, Drop of Hb, postop pain, duration of hospital stay, intraop complication, postop complication are willing to be measured.
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 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cosmetic OutcomesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JungRyoel Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826578
- Sponsor's protocol ID
- jrlee01
- Acronym
- SM
- Status last verified
- Apr 2013
- First submitted
- 22 Mar 2013
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial to Analyze the Benefits of Single Port Laparoscopic Myomectomy in the View of Cosmetics and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT01826578
- Acronym / sponsor ID
- SM / jrlee01
- Conditions
- Cosmetic Outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Apr 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.
This study is about the evaluation of which benefits single port laparoscopic myomectomy has in the perspective of cosmetics and patient satisfaction.
Detailed description
There were several studies about feasibility and cosmetic benefit of single port laparoscopic adnexal surgery and hysterectomy compared to conventional multiport laparoscopic surgery. Meanwhile, no study mentioned benefit of single port laparoscopic surgery in myomectomy because single port myomectomy needs more labor and operator's skill than other pelvic surgery. At this point, the investigators need to verify the effectiveness and benefit of single port laparoscopic myomectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single port arm | Experimental | Procedure: using only one port for laparoscopic surgery |
| Conventional arm | No intervention | –Using 3-4 port for laparosocpic surgery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- premenopausal women
- image confirmed myoma
- scheduled to have laparoscopic myomectomy
- number of myoma =<4 and largest size <10cm
Key exclusion criteria (5 listed)
- scheduled to have co-operation of other surgery
- clinically significant hematologic abnormality
- DM or malnutrition
- under the medication which can affect wound healing
- previous history of other pelvic surgery
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 |
|---|---|---|
| using only one port for laparoscopic surgeryAlso: Single port interventionusing only one port for laparoscopic surgery | Procedure or surgery | single port arm |
Primary outcome
Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of scar evaluation
Time frame: for 8 weeks
The characteristics of scar such as color, pliability, and stiffness are willing to be measured in 1 week and 8 week later after myomectomy. The level of satisfaction of patients will also be evaluated.
Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of patient satisfaction
Time frame: for 8 weeks
Patient satisfaction about scar formation after myomectomy are willing to be evaluated after surgery.
1 secondary outcome
General composite characteristics of surgery procedure and outcome
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 Apr 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using only one port for laparoscopic surgery in people with Cosmetic Outcomes, run by Seoul National University Hospital at 1 site 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 4 inclusion and 5 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 Apr 2013. 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 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.
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?
Contact JungRyoel Lee, assistant professor (82-10-8714-6870, leejrmd@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of scar evaluation (time frame: for 8 weeks). The study lists 2 primary outcomes in all. 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 Apr 2013.