LaparoscopyNCT04070716
3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy
A study testing 3D laparoscope and 2D laparoscope in people with Laparoscopy, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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.. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Laparoscopy
- What is being tested?
- 3D laparoscope and 2D laparoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Aug 2019to 23 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uterine myoma requiring laparoscopic myomectomy
- American Society of Anesthesiologists physical status (ASAPS) classification I-II
- absence of pregnancy at the time of surgery.
Who cannot join
- any suspicious findings of malignant gynecologic diseases,
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
Taejong Song, 1040358405, taejong.song@gmail.com
About this study
Official title: 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..
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..
- Conditions
- Laparoscopy
- Being tested
- 3D laparoscope, 2D laparoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D laparoscopeProcedure or surgery
For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.
2D laparoscopeProcedure or surgery
For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.
| Study group | Role | What they receive |
|---|---|---|
| 3D laparoscope | Experimental | For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group. Receives: 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. Receives: Procedure: 2D laparoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of surgery
Secondary outcomes (1)
Operative time
Operative time was defined as the time from incision to closure of the skin.
Measured: At the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start23 Aug 2019
- Primary completion23 Aug 2019 (estimated)
- Study completion23 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taejong Song, Kangbuk Samsung Hospital
- Investigators
- Taejong Song, MD PhD, Principal investigator, Kangbuk Samsung Hospital, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070716
- Sponsor's protocol ID
- KBSMC 2019-08-022
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-dimensional Versus 2-dimensional Laparoscopy for Myomectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04070716
- Acronym / sponsor ID
- KBSMC 2019-08-022
- Conditions
- Laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 23 Aug 2019 (estimated)
- Study completion
- 23 Aug 2019 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D laparoscope | Experimental | Procedure: 3D laparoscopeFor laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group. |
| 2D laparoscope | Experimental | Procedure: 2D laparoscopeFor laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Uterine myoma requiring laparoscopic myomectomy
- American Society of Anesthesiologists physical status (ASAPS) classification I-II
- absence of pregnancy at the time of surgery.
Key exclusion criteria (1 listed)
- any suspicious findings of malignant gynecologic diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D laparoscopeFor laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group. | Procedure or surgery | 3D laparoscope |
| 2D laparoscopeFor laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group. | Procedure or surgery | 2D laparoscope |
Primary outcome
Amount of operative blood loss
Time frame: 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.
1 secondary outcome
Operative time
Time frame: At the day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taejong Song, MD PhD principal investigator
Kangbuk Samsung Hospital, Seoul, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D laparoscope and 2D laparoscope in people with Laparoscopy, run by Kangbuk Samsung Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taejong Song, MD PhD (+821040358405, taejong.song@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of operative blood loss (time frame: At the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.