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Clinical Trials/NCT04070716
NCT04070716
Unknown
N/A

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

Kangbuk Samsung Hospital1 site in 1 country64 target enrollmentAugust 23, 2019
ConditionsLaparoscopy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Laparoscopy
Sponsor
Kangbuk Samsung Hospital
Enrollment
64
Locations
1
Primary Endpoint
Amount of operative blood loss
Last Updated
6 years ago

Overview

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..

Registry
clinicaltrials.gov
Start Date
August 23, 2019
End Date
August 23, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Kangbuk Samsung Hospital
Responsible Party
Principal Investigator
Principal Investigator

Taejong Song

Professor

Kangbuk Samsung Hospital

Eligibility Criteria

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,

Outcomes

Primary Outcomes

Amount of operative blood loss

Time Frame: At the time of surgery

Amount 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 Outcomes

  • Operative time(At the day of surgery)

Study Sites (1)

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