3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy

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

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..

Study Overview

• Status: Unknown
• Conditions: Laparoscopy
• Intervention / Treatment: Procedure: 3D laparoscope; Procedure: 2D laparoscope

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..

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03181
    • Recruiting
    • Kangbuk Samsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of operative blood loss	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.	At the time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Operative time was defined as the time from incision to closure of the skin.	At the day of surgery

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2019
• Primary Completion (Anticipated): August 23, 2019
• Study Completion (Anticipated): August 23, 2019

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 25, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 25, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: KBSMC 2019-08-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No