An interventional study of 3D laparoscope and 2D laparoscope in Laparoscopy, sponsored by Kangbuk Samsung Hospital. Completed at 1 site in South Korea. Open to female participants aged 19 Years to 48 Years. Per ClinicalTrials.gov, last updated 2019-03-14.
Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Treatment
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.
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.
Kangbuk Samsung Hospital is the lead sponsor of 63 studies on the registry; 9 are open to participants now.
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For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.
Procedure: 3D laparoscope
For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.
Procedure: 2D laparoscope
For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.
For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.
Operative blood loss
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
physical demand
The physical demand was evaluated on a scale of 0 to 10 using the question of "How physically demanding was the task?" High score means high physical demand. Low score means low physical demand.
Time frame: At the time of surgery
mental demand
The mental demand was evaluated on a scale of 0 to 10 using the question of "How mentally demanding was the task?" High score means high mental demand. Low score means low mental demand.
Time frame: At the time of surgery
visually induced motion sickness (VIMS)
The vision-induced motion sickness (VIMS) was assess using the Simulator Sickness Questionnaire (SSQ), in which higher score indicates worse sickness. The maximum and minimum score of SSQ are 48 and 0 points.
Time frame: At the time of surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Mar 2019, 10 months.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Kangbuk Samsung Hospital