Single Port Myomectomy Versus Conventional Myomectomy (SM)
This study is about the evaluation of which benefits single port laparoscopic myomectomy has in the perspective of cosmetics and patient satisfaction.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Controlled Trial to Analyze the Benefits of Single Port Laparoscopic Myomectomy in the View of Cosmetics and Patient Satisfaction|
- Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of scar evaluation [ Time Frame: for 8 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Patient satisfaction about scar formation after myomectomy are willing to be evaluated after surgery.
- General composite characteristics of surgery procedure and outcome [ Time Frame: 1 week ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
|Experimental: single port arm||
Procedure: using only one port for laparoscopic surgery
using only one port for laparoscopic surgery
Other Name: Single port intervention
No Intervention: Conventional arm
Using 3-4 port for laparosocpic surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01826578
|Contact: JungRyoel Lee, assistant firstname.lastname@example.org|
|Korea, Republic of|
|Seoul University Bundang Hospital OB & GY||Not yet recruiting|
|Sungnam-si, Kyeonggi-do, Korea, Republic of, 463-707|