Single Port Myomectomy Versus Conventional Myomectomy

Not Applicable

• Conditions: Cosmetic Outcomes
• Interventions: Procedure: using only one port for laparoscopic surgery

• Registration Number: NCT01826578
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2013-03-22
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-03
• Last Update Submitted: 2013-04-03
• Study First Posted: 2013-04-08
• Last Update Posted: 2013-04-08
• Study Start: 2013-05
• Primary Completion: 2014-09
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 106

Inclusion Criteria

• premenopausal women
• image confirmed myoma
• scheduled to have laparoscopic myomectomy
• number of myoma =<4 and largest size <10cm

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single port arm	using only one port for laparoscopic surgery	-

Primary Outcome Measures

Name	Time	Method
Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of scar evaluation	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	for 8 weeks	Patient satisfaction about scar formation after myomectomy are willing to be evaluated after surgery.

Secondary Outcome Measures

Name	Time	Method
General composite characteristics of surgery procedure and outcome	1 week	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.

Trial Locations

Locations (1)

Seoul University Bundang Hospital OB & GY; 🇰🇷 Sungnam-si, Kyeonggi-do, Korea, Republic of