Single Port Myomectomy Versus Conventional Myomectomy (SM)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
JungRyoel Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01826578
First received: March 22, 2013
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
Cosmetic Outcomes
Procedure: using only one port for laparoscopic surgery

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 106
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)
Arms Assigned Interventions
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

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.

  Eligibility

Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: JungRyoel Lee, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01826578     History of Changes
Other Study ID Numbers: jrlee01
Study First Received: March 22, 2013
Last Updated: April 3, 2013
Health Authority: Korea: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014