3-dimensional Versus 2-dimensional Laparoscopy of Ovarian Cyst
LOOC
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2018
CompletedFirst Posted
Study publicly available on registry
March 5, 2018
CompletedStudy Start
First participant enrolled
May 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2019
CompletedMarch 14, 2019
March 1, 2019
10 months
February 27, 2018
March 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
At the time of surgery
Secondary Outcomes (3)
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 Arms (2)
3D laparoscope
EXPERIMENTALFor laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.
2D laparoscope
EXPERIMENTALFor laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- age between 19 and 48 years
- American Society of Anesthesiologists physical status (ASAPS) classification I-II
- absence of pregnancy at the time of surgery.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kangbuk Samsung Hospital
Seoul, Jongno-gu, 03181, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Taejong Song, MD PhD
Kangbuk Samsung Hospital, Seoul, Republic of Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 27, 2018
First Posted
March 5, 2018
Study Start
May 10, 2018
Primary Completion
March 12, 2019
Study Completion
March 12, 2019
Last Updated
March 14, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share