NCT04070716

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..

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 23, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

Same day

First QC Date

August 23, 2019

Last Update Submit

August 25, 2019

Conditions

Laparoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Operative time

    At the day of surgery

Study Arms (2)

3D laparoscope

EXPERIMENTAL

For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.

Procedure: 3D laparoscope

2D laparoscope

EXPERIMENTAL

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

Interventions

3D laparoscopePROCEDURE

For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.

3D laparoscope
2D laparoscopePROCEDURE

For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.

2D laparoscope

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uterine myoma requiring laparoscopic myomectomy
  • American Society of Anesthesiologists physical status (ASAPS) classification I-II
  • absence of pregnancy at the time of surgery.

You may not qualify if:

  • any suspicious findings of malignant gynecologic diseases,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

RECRUITING

Study Officials

  • Taejong Song, MD PhD

    Kangbuk Samsung Hospital, Seoul, Republic of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taejong Song, MD PhD

CONTACT

+821040358405taejong.song@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

August 23, 2019

Primary Completion

August 23, 2019

Study Completion

August 23, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)