3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy

Kangbuk Samsung Hospital64 enrolled

Overview

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..

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..

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Laparoscopy

Interventions

3D laparoscopePROCEDURE

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

2D laparoscopePROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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,

Locations (1)

Kangbuk Samsung Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Amount of operative blood loss

Amount of operative blood loss was measured by the anesthesiologists after defining it as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery.

Time frame: At the time of surgery

Secondary Outcomes

Operative time

Operative time was defined as the time from incision to closure of the skin.

Time frame: At the day of surgery

Central Contacts

Taejong Song, MD PhD

CONTACT

+821040358405 taejong.song@gmail.com

Data from ClinicalTrials.gov

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