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Clinical Trials/NCT03453333
NCT03453333CompletedNot Applicable

3-dimensional Versus 2-dimensional Laparoscopy Of Ovarian Cyst (LOOC): a Randomized Controlled Trial

Kangbuk Samsung Hospital2 sites in 1 country46 target enrollmentStarted: May 10, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
46
Locations
2
Primary Endpoint
Operative blood loss

Study Overview

Brief Summary

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 48 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

3D laparoscope

Experimental

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

Intervention: 3D laparoscope (Procedure)

2D laparoscope

Experimental

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

Intervention: 2D laparoscope (Procedure)

Outcomes

Primary Outcomes

Operative blood loss

Time Frame: At the time of surgery

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.

Secondary Outcomes

  • physical demand(At the time of surgery)
  • mental demand(At the time of surgery)
  • visually induced motion sickness (VIMS)(At the time of surgery)

Investigators

Sponsor
Kangbuk Samsung Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Taejong Song

Professor

Kangbuk Samsung Hospital

Study Sites (2)

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