Single Port Myomectomy Versus Conventional Myomectomy (SM)

April 3, 2013 updated by: JungRyoel Lee, Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kyeonggi-do
      • Sungnam-si, Kyeonggi-do, Korea, Republic of, 463-707
        • Seoul University Bundang Hospital OB & GY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single port arm
Procedure: using only one port for laparoscopic surgery
using only one port for laparoscopic surgery
Other Names:
  • Single port intervention
No Intervention: Conventional arm
Using 3-4 port for laparosocpic surgery

What is the study measuring?

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
Time Frame: 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.
for 8 weeks
Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of patient satisfaction
Time Frame: for 8 weeks
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
Time Frame: 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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Estimate)

April 8, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • jrlee01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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