3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy

Not Applicable

• Conditions: Laparoscopy
• Interventions: Procedure: 2D laparoscope; Procedure: 3D laparoscope

• Registration Number: NCT04070716
• Lead Sponsor: Kangbuk Samsung Hospital

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..

Study Timeline

• Status Verified: 2019-08
• Study Start: 2019-08-23
• Primary Completion: 2019-08-23
• Study Completion: 2019-08-23
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-25
• Last Update Submitted: 2019-08-25
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Amount of operative blood loss	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 Outcome Measures

Name	Time	Method
Operative time	At the day of surgery	Operative time was defined as the time from incision to closure of the skin.

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of