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Single Port Myomectomy Versus Conventional Myomectomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01826578
Acronym
SM
Enrollment
106
Registered
2013-04-08
Start date
2013-05-31
Completion date
2014-12-31
Last updated
2013-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cosmetic Outcomes

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.

Interventions

PROCEDUREusing only one port for laparoscopic surgery

using only one port for laparoscopic surgery

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of scar evaluationfor 8 weeksThe 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 satisfactionfor 8 weeksPatient satisfaction about scar formation after myomectomy are willing to be evaluated after surgery.

Secondary

MeasureTime frameDescription
General composite characteristics of surgery procedure and outcome1 weekComposite 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.

Countries

South Korea

Contacts

Primary ContactJungRyoel Lee, assistant professor
leejrmd@snu.ac.kr82-10-8714-6870

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026