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3-dimensional Versus 2-dimensional Laparoscopy of Ovarian Cyst (LOOC)

Primary Purpose

Laparoscopy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
3D laparoscope
2D laparoscope
Sponsored by
Kangbuk Samsung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopy

Eligibility Criteria

19 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kangbuk Samsung Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3D laparoscope

2D laparoscope

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 27, 2018
Last Updated
March 12, 2019
Sponsor
Kangbuk Samsung Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03453333
Brief Title
3-dimensional Versus 2-dimensional Laparoscopy of Ovarian Cyst
Acronym
LOOC
Official Title
3-dimensional Versus 2-dimensional Laparoscopy Of Ovarian Cyst (LOOC): a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
March 12, 2019 (Actual)
Study Completion Date
March 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D laparoscope
Arm Type
Experimental
Arm Description
For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.
Arm Title
2D laparoscope
Arm Type
Experimental
Arm Description
For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.
Intervention Type
Procedure
Intervention Name(s)
3D laparoscope
Intervention Description
For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.
Intervention Type
Procedure
Intervention Name(s)
2D laparoscope
Intervention Description
For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.
Primary Outcome Measure Information:
Title
Operative blood loss
Description
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
Secondary Outcome Measure Information:
Title
physical demand
Description
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
Title
mental demand
Description
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
Title
visually induced motion sickness (VIMS)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taejong Song, MD PhD
Organizational Affiliation
Kangbuk Samsung Hospital, Seoul, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03181
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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3-dimensional Versus 2-dimensional Laparoscopy of Ovarian Cyst

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