CClinicalTrials.gg
Status unknownNCT04070716Updated Aug 28, 2019

3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy

An interventional study of 3D laparoscope and 2D laparoscope in Laparoscopy, sponsored by Kangbuk Samsung Hospital. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
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Study 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..

Read the 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..

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Conditions studied

  • Laparoscopy
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In context

Lead sponsor

Kangbuk Samsung Hospital is the lead sponsor of 59 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • any suspicious findings of malignant gynecologic diseases,
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Procedure3D laparoscope

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

  • Procedure2D laparoscope

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

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What researchers measure

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.

    Time frame: At the time of surgery

Secondary outcomes

  1. Operative time

    Operative time was defined as the time from incision to closure of the skin.

    Time frame: At the day of surgery

07

Study locations

1 of 1 sites recruiting
  • Kangbuk Samsung Hospital
    Seoul, 03181, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04070716
Lead sponsor
Kangbuk Samsung Hospital
Responsible party
Taejong Song (Professor, Kangbuk Samsung Hospital) — Principal investigator
First posted
Aug 28, 2019
Start date
Aug 23, 2019
Primary completion
Aug 23, 2019 (estimated)
Completion
Aug 23, 2019 (estimated)
Last update
Aug 28, 2019

Study contacts

Taejong Song, MD PhD
Contact
taejong.song@gmail.com
+821040358405
Taejong Song, MD PhD
principal investigator · Kangbuk Samsung Hospital, Seoul, Republic of Korea

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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