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Clinical Trials/NCT03453333
NCT03453333
Completed
Not Applicable

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

Kangbuk Samsung Hospital1 site in 1 country46 target enrollmentMay 10, 2018
ConditionsLaparoscopy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laparoscopy
Sponsor
Kangbuk Samsung Hospital
Enrollment
46
Locations
1
Primary Endpoint
Operative blood loss
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 10, 2018
End Date
March 12, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Kangbuk Samsung Hospital
Responsible Party
Principal Investigator
Principal Investigator

Taejong Song

Professor

Kangbuk Samsung Hospital

Eligibility Criteria

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

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)

Study Sites (1)

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