Single Port Myomectomy Versus Conventional Myomectomy

Study Overview
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Brief Summary
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This study is about the evaluation of which benefits single port laparoscopic myomectomy has in the perspective of cosmetics and patient satisfaction.

Detailed Description
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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.

Official Title
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Prospective Randomized Controlled Trial to Analyze the Benefits of Single Port Laparoscopic Myomectomy in the View of Cosmetics and Patient Satisfaction

Conditions
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Cosmetic Outcomes

Intervention / Treatment
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* Procedure: using only one port for laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: premenopausal women image confirmed myoma scheduled to have laparoscopic myomectomy number of myoma =<4 and largest size <10cm Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single port arm<br> | Procedure: using only one port for laparoscopic surgery<br>* using only one port for laparoscopic surgery<br>* Other names: Single port intervention;|
| No Intervention: Conventional arm<br>Using 3-4 port for laparosocpic surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | for 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week |