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3-dimensional Versus 2-dimensional Laparoscopy for Hysterectomy

K

Kangbuk Samsung Hospital

Status

Unknown

Conditions

Laparoscopy

Treatments

Procedure: 2D laparoscope
Procedure: 3D laparoscope

Study type

Interventional

Funder types

Other

Identifiers

NCT04070872
KBSMC 2019-08-023

Details and patient eligibility

About

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 hysterectomy.

Full 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 hysterectomy. 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 hysterectomy.

Enrollment

68 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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,

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

68 participants in 2 patient groups

3D laparoscope
Experimental group
Description:
For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.
Treatment:
Procedure: 3D laparoscope
2D laparoscope
Experimental group
Description:
For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.
Treatment:
Procedure: 2D laparoscope

Trial contacts and locations

1

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Central trial contact

Taejong Song, MD PhD

Data sourced from clinicaltrials.gov

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