We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single Port Myomectomy Versus Conventional Myomectomy (SM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01826578
Recruitment Status : Unknown
Verified April 2013 by JungRyoel Lee, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 8, 2013
Last Update Posted : April 8, 2013
Sponsor:
Information provided by (Responsible Party):
JungRyoel Lee, 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.

Condition or disease Intervention/treatment
Cosmetic Outcomes Procedure: using only one port for laparoscopic surgery

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  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826578


Contacts
Contact: JungRyoel Lee, assistant professor 82-10-8714-6870 leejrmd@snu.ac.kr

Locations
Korea, Republic of
Seoul University Bundang Hospital OB & GY Not yet recruiting
Sungnam-si, Kyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: JungRyoel Lee, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01826578     History of Changes
Other Study ID Numbers: jrlee01
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013