NCT01826578

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

March 22, 2013

Last Update Submit

April 3, 2013

Conditions

Cosmetic Outcomes

Outcome Measures

Primary Outcomes (2)

  • Cosmetic benefits of single port laparoscopic myomectomy to conventional myomectomy in the view of scar evaluation

    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

    Patient satisfaction about scar formation after myomectomy are willing to be evaluated after surgery.

    for 8 weeks

Secondary Outcomes (1)

  • General composite characteristics of surgery procedure and outcome

    1 week

Study Arms (2)

single port arm

EXPERIMENTAL
Procedure: using only one port for laparoscopic surgery

Conventional arm

NO INTERVENTION

Using 3-4 port for laparosocpic surgery

Interventions

using only one port for laparoscopic surgeryPROCEDURE

using only one port for laparoscopic surgery

Also known as: Single port intervention
single port arm

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • premenopausal women
  • image confirmed myoma
  • scheduled to have laparoscopic myomectomy
  • number of myoma =\<4 and largest size \<10cm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul University Bundang Hospital OB & GY

Sungnam-si, Kyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

JungRyoel Lee, assistant professor

CONTACT

82-10-8714-6870leejrmd@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 22, 2013

First Posted

April 8, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations

KR(1)