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3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy

3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy: a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04070716
Enrollment
64
Registered
2019-08-28
Start date
2019-08-23
Completion date
2019-08-23
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopy

Brief summary

The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic myomectomy..

Detailed description

Laparoscopy is founded as a treatment of choice for benign uterine disease. 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 demanding compared with open surgery because operators should project three-dimensional (3D) field through a two-dimensional (2D) monitor. However, to date, studies examining the possible benefits and drawbacks of 3D imaging system versus 2D in laparoscopic surgery have brought about conflicting results. Moreover, there have been few studies comparing the surgical outcomes of 3D and 2D laparoscopic laparoscopic myomectomy. The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic myomectomy..

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.

Sponsors

Kangbuk Samsung Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Uterine myoma requiring laparoscopic myomectomy * American Society of Anesthesiologists physical status (ASAPS) classification I-II * absence of pregnancy at the time of surgery.

Exclusion criteria

* any suspicious findings of malignant gynecologic diseases,

Design outcomes

Primary

MeasureTime frameDescription
Amount of operative blood lossAt the time of surgeryAmount of 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

MeasureTime frameDescription
Operative timeAt the day of surgeryOperative time was defined as the time from incision to closure of the skin.

Countries

South Korea

Contacts

Primary ContactTaejong Song, MD PhD
taejong.song@gmail.com+821040358405

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026