Kangbuk Samsung Hospital
Seoul, Jongno-gu, 03181, South Korea
NCT Number: NCT03453333
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.
Looking for future studies?
Notify Me19 year–48 year
Female
Interventional
Not applicable
Seoul, Jongno-gu, 03181, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: At the time of surgery
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
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
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.
Kangbuk Samsung Hospital
Other
3-dimensional Versus 2-dimensional Laparoscopy Of Ovarian Cyst (LOOC): a Randomized Controlled Trial
Acronym: LOOC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05019612
Endometriosis, Expectations
Hamburg, Germany
View Trial DetailsNCT05206279
Deep Infiltrative Endometriosis, Endometriosis
Bern, Switzerland
View Trial DetailsNCT07026162
Gynecologic Surgical Procedures, Laparoscopy
Changsha, Hunan, China
View Trial DetailsNCT05839587
Hernia, Hernia, Abdominal
Aabenraa, Denmark
View Trial Details