3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy

NCT ID: NCT04070716

Last Updated: 2019-08-28

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-23

Study Completion Date

2019-08-23

Brief Summary

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The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic myomectomy..

Detailed Description

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Laparoscopy is founded as a treatment of choice for benign uterine disease. The advantages of laparoscopic surgery over conventional open surgery are less pain, shorter recovery time, shorter hospital stay, and consequently faster return to normal activity as well as better cosmetic effects. However, laparoscopic surgery is more demanding compared with open surgery because operators should project three-dimensional (3D) field through a two-dimensional (2D) monitor.

However, to date, studies examining the possible benefits and drawbacks of 3D imaging system versus 2D in laparoscopic surgery have brought about conflicting results. Moreover, there have been few studies comparing the surgical outcomes of 3D and 2D laparoscopic laparoscopic myomectomy. The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic myomectomy..

Conditions

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Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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3D laparoscope

For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.

Group Type EXPERIMENTAL

3D laparoscope

Intervention Type PROCEDURE

For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.

2D laparoscope

For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.

Group Type EXPERIMENTAL

2D laparoscope

Intervention Type PROCEDURE

For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.

Interventions

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3D laparoscope

For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.

Intervention Type PROCEDURE

2D laparoscope

For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Uterine myoma requiring laparoscopic myomectomy
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* absence of pregnancy at the time of surgery.

Exclusion Criteria

* any suspicious findings of malignant gynecologic diseases,
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Taejong Song

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taejong Song, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital, Seoul, Republic of Korea

Locations

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Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Taejong Song, MD PhD

Role: CONTACT

+821040358405

Facility Contacts

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Taejong Song

Role: primary

1040358405

Other Identifiers

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KBSMC 2019-08-022

Identifier Type: -

Identifier Source: org_study_id

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