3-dimensional Versus 2-dimensional Laparoscopy for Hysterectomy

Kangbuk Samsung Hospital

Status: Unknown

Conditions: Laparoscopy

Treatments: Procedure: 2D laparoscope; Procedure: 3D laparoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT04070872

KBSMC 2019-08-023

Details and patient eligibility

About

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 hysterectomy.

Full description

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 hysterectomy. 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 hysterectomy.

Enrollment: 68 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

3D laparoscope

Experimental group

Description:

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

Treatment:

Procedure: 3D laparoscope

2D laparoscope

Experimental group

Description:

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

Treatment:

Procedure: 2D laparoscope