Clinical trial NCT03453333: 3-dimensional Versus 2-dimensional Laparoscopy of Ovarian Cyst
Official title: 3-dimensional Versus 2-dimensional Laparoscopy Of Ovarian Cyst (LOOC): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopy
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 46
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Operative blood loss
timeFrame: At the time of surgery
Secondary outcomes:
measure: physical demand
timeFrame: At the time of surgery
measure: mental demand
timeFrame: At the time of surgery
measure: visually induced motion sickness (VIMS)
timeFrame: At the time of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Jongno-gu
Study officials:
affiliation: Kangbuk Samsung Hospital, Seoul, Republic of Korea
name: Taejong Song, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: