Single Port Myomectomy Versus Conventional Myomectomy (SM)

Seoul National University

Status: Unknown

Conditions: Cosmetic Outcomes

Treatments: Procedure: using only one port for laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01826578

jrlee01

Details and patient eligibility

About

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

Full 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.

Enrollment: 106 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

single port arm

Experimental group

Treatment:

Procedure: using only one port for laparoscopic surgery

Conventional arm

No Intervention group

Description:

Using 3-4 port for laparosocpic surgery