Single Port Myomectomy Versus Conventional Myomectomy

NCT ID: NCT01826578

Last Updated: 2013-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cosmetic Outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single port arm

Group Type EXPERIMENTAL

using only one port for laparoscopic surgery

Intervention Type PROCEDURE

using only one port for laparoscopic surgery

Conventional arm

Using 3-4 port for laparosocpic surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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using only one port for laparoscopic surgery

using only one port for laparoscopic surgery

Intervention Type PROCEDURE

Other Intervention Names

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Single port intervention

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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JungRyoel Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul University Bundang Hospital OB & GY

Sungnam-si, Kyeonggi-do, South Korea

Site Status

Countries

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South Korea

Central Contacts

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JungRyoel Lee, assistant professor

Role: CONTACT

82-10-8714-6870

Other Identifiers

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jrlee01

Identifier Type: -

Identifier Source: org_study_id

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