3-dimensional Versus 2-dimensional Laparoscopy of Ovarian Cyst (LOOC)

Kangbuk Samsung Hospital

Status: Completed

Conditions: Laparoscopy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03453333

KBSMC 2018-04-023

Details and patient eligibility

About

Lack of depth perception and spatial orientation are drawbacks of laparoscopic surgery. The advent of the three-dimensional (3D) camera system enables surgeons to regain binocular vision. The aim of this study was to gain subjective and objective data to determine whether 3D systems are superior to two-dimensional (2D) systems in terms of surgical outcomes.

Full description

Elective laparoscopic ovarian cystectomy is established as the treatment of choice for benign ovarian cysts. 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 challenging compared with open surgery, partly because surgeons must operate in a three-dimensional (3D) space through a two-dimensional (2D) projection on a monitor, which results in loss of depth perception and consequently more cognitive workload on the surgeon. In traditional 2D laparoscopic procedures, the surgeon has to mentally transform and process the 2D image into a 3D image using motion parallax through movement of the laparoscope, relative position of instruments, and shading of light and dark. During the past 3 decades, 3D imaging systems have been introduced in and attempt to improve in-depth perception and spatial orientation during minimally invasive surgery. The anticipated advantages for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, a reduced learning curve, and enhanced safety.

Nevertheless, studies, to date, examining the potential advantages and disadvantages of 3D versus 2D imaging systems have produced contradictory results. Moreover, there have been no studies exploring the advantage of 3D imaging system in patients undergoing laparoscopic ovarian cystectomy. The aim of this study was to gain subjective and objective data to determine whether 3D imaging systems in the treatment of ovarian cyst are superior to 2D systems in terms of surgical outcomes.

Enrollment: 46 patients

Sex: Female

Ages: 19 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 19 and 48 years
• American Society of Anesthesiologists physical status (ASAPS) classification I-II
• absence of pregnancy at the time of surgery.

Exclusion criteria

• any suspicious finding of malignant ovarian diseases
• any concomitant diseases requiring uterine or upper abdominal surgery
• unavailability of the surgical recording equipment for laparoscopic procedure
• post-menopausal status

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 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