3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04070716
• Other study ID #: KBSMC 2019-08-022
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2019
• Est. completion date: August 23, 2019

Study information

• Verified date: August 2019
• Source: Kangbuk Samsung Hospital
• Contact: Taejong Song, MD PhD
• Phone: +821040358405
• Email: taejong.song[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: August 23, 2019
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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,

Related Conditions & MeSH terms

• Laparoscopy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative time	Operative time was defined as the time from incision to closure of the skin.	At the day of surgery