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Surgical Procedure, UnspecifiedNCT02775344

3D Versus 2D Laparoscopic Ovarian Cystectomy

A study testing Three dimension laparoscopy in people with Surgical Procedure, Unspecified, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective randomized study involving 80 patients. All participates will be given written information on 3D laparoscopy. They will be randomized according to computer-generated random sequence into two groups, 2D and 3D group. The operation will then be performed either using 2D or 3D laparoscopy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Surgical Procedure, Unspecified
What is being tested?
Three dimension laparoscopy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteHong Kong
Study dates
May 2014to Aug 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Planned for laparoscopic ovarian cystectomy
  • Willing and able to participate after the study has been explained
  • Those understand either Cantonese, Putonghua or English

Who cannot join

  • essential data are missing from the participants records making it impossible to judge treatment outcome.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Department of Obstetrics and Gynaecology, Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Comparison of Three-dimension Versus Two-dimension Laparoscopic Ovarian Cystectomy

This is a prospective randomized study involving 80 patients. All participates will be given written information on 3D laparoscopy. They will be randomized according to computer-generated random sequence into two groups, 2D and 3D group. The operation will then be performed either using 2D or 3D laparoscopy. Surgeons are allowed to change to the other type of laparoscopy if difficulty encountered. After the operation, the surgeons will be required to fill in a questionnaire self-evaluating the performance using Global rating scale component of the intraoperative assessment tool (GOALS), any discomfort encountered, any need for change of laparoscopy and their preference on the type of laparoscopy.

The level of complexity of the operation, duration of operation, blood loss and complications will be recorded.

Read the detailed description

Laparoscopy has greatly replaced laparotomy in most gynaecological operations including oncological procedures. Laparoscopic approach is the mainstay for ovarian cystectomy nowadays. However the loss of depth perception and dexterity remains the drawback of laparoscopy. With the development of robotic surgery, the three-dimension vision and presence of "wrist" motion allowed surgeon to perform more complicated operations in sophisticated manner. Expensive instruments and the need for prolonged time of setup restricted the extensive use of it. Having those considerations in mind, three-dimension (3D) laparoscopy is another possible alternative. With the advancement of technology in 3D vision, it may provide better precision especially in perception of depth and spatial orientation. Dizziness, nausea, headache and ocular fatique are occasional side effects in 3D surgery which created concerns of the surgeons.

There have been studies using standardized tasks shown that 3D laparoscopy will improve the performance in surgeon both objectively and subjectively especially when performing complex task. It was suggested to be able to fasten the learning curve for beginners. The operation time was shorter when laparoscopic cholecystectomy was performed using 3D imaging without any major complications encountered.

Yet evidence in the applicability and use in clinical service in gynaecological operations are still inadequate. The investigators would like to evaluate the difference of 2D versus 3D laparoscopic ovarian cystectomy.

Being tested
Three dimension laparoscopy
Keywords
Laparoscopy, ovarian cystectomy, three dimension laparoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Three dimension laparoscopyDevice

    Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy.

Study groups in NCT02775344
Study groupRoleWhat they receive
three dimension laparoscopyExperimentalThis group of patients will have laparoscopic ovarian cystectomy performed using three-dimension laparoscopy. The procedure will be performed in usual manner.
Receives: Device: Three dimension laparoscopy
Two dimension laparoscopyNo interventionTwo-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Duration of Laparoscopic Ovarian Cystectomy

    The duration of laparoscopic ovarian cystectomy will be recorded. It is defined as from insertion of primary port insertion till completion of performance of ovarian cystectomy. The time required for specimen retrieval will not be included.

    Measured: duration of operation, up to 120 minutes

  2. Global Rating Scale Component of the Intraoperative Assessment Tool (GOALS) Score

    Surgeons are required to fill in a questionnaire using GOALS. It involved seven aspects - depth perception, bimanual dexterity, efficiency, tissue handling, autonomy, sharpness and image resolution. Each aspects scored 0 to 5 with higher the value, better the performance. The sum of the 7 aspects were used in comparison between groups with a maximum score of 35.

    Measured: During the operation, up to 120 minutes

Secondary outcomes (5)

  1. Number of Surgeons Encountered Side Effects

    Dizziness, nausea and ocular fatique are common side effects of 3D laparoscopy. The number of surgeons experienced discomfort will be reported and any additional discomfort will be recorded.

    Measured: during the operation, up to 120 minutes

  2. Preference of Surgeons

    Surgeons need to indicate their preference of 3D or 2D laparoscopy after the surgery.

    Measured: during the operation, up to 120 minutes

  3. Need for Change of Instrument

    The surgeons are allowed to switch from 3D laparoscopy to tranditional 2D laparoscopy if deemed necessary by the surgeons. The reason for switch of instrument will be recorded as well.

    Measured: during the operation, up to 120 minutes

  4. Total Blood Loss During Operation

    The total amount of blood loss during operation was recorded.

    Measured: during the operation, up to 120 minutes

  5. Duration of Hospital Stay

    The total duration of hospital stay was recorded.

    Measured: Postoperative up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study startMay 2014
  3. Primary completionMay 2016
  4. Study completionAug 2016

Resources

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
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02775344
Sponsor's protocol ID
UW 14-096
Status last verified
Nov 2019
First submitted
12 May 2016
Last updated
25 Nov 2019
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Storz P, Buess GF, Kunert W, Kirschniak A. 3D HD versus 2D HD: surgical task efficiency in standardised phantom tasks. Surg Endosc. 2012 May;26(5):1454-60. doi: 10.1007/s00464-011-2055-9. Epub 2011 Dec 17.

    PubMed 22179446

  • Lusch A, Bucur PL, Menhadji AD, Okhunov Z, Liss MA, Perez-Lanzac A, McDougall EM, Landman J. Evaluation of the impact of three-dimensional vision on laparoscopic performance. J Endourol. 2014 Feb;28(2):261-6. doi: 10.1089/end.2013.0344. Epub 2014 Jan 10.

    PubMed 24059674

  • Tanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the fundamentals of laparoscopic surgery skill set. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):865-70. doi: 10.1089/lap.2012.0220. Epub 2012 Oct 16.

    PubMed 23072406

  • Wagner OJ, Hagen M, Kurmann A, Horgan S, Candinas D, Vorburger SA. Three-dimensional vision enhances task performance independently of the surgical method. Surg Endosc. 2012 Oct;26(10):2961-8. doi: 10.1007/s00464-012-2295-3. Epub 2012 May 12.

    PubMed 22580874

  • Cicione A, Autorino R, Breda A, De Sio M, Damiano R, Fusco F, Greco F, Carvalho-Dias E, Mota P, Nogueira C, Pinho P, Mirone V, Correia-Pinto J, Rassweiler J, Lima E. Three-dimensional vs standard laparoscopy: comparative assessment using a validated program for laparoscopic urologic skills. Urology. 2013 Dec;82(6):1444-50. doi: 10.1016/j.urology.2013.07.047. Epub 2013 Oct 2.

    PubMed 24094658

  • Vassiliou MC, Feldman LS, Andrew CG, Bergman S, Leffondre K, Stanbridge D, Fried GM. A global assessment tool for evaluation of intraoperative laparoscopic skills. Am J Surg. 2005 Jul;190(1):107-13. doi: 10.1016/j.amjsurg.2005.04.004.

    PubMed 15972181

  • Bilgen K, Ustun M, Karakahya M, Isik S, Sengul S, Cetinkunar S, Kucukpinar TH. Comparison of 3D imaging and 2D imaging for performance time of laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2013 Apr;23(2):180-3. doi: 10.1097/SLE.0b013e3182827e17.

    PubMed 23579515

Questions about this trial

What is this clinical trial studying?

A study testing Three dimension laparoscopy in people with Surgical Procedure, Unspecified, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.

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: finished, as of the sponsor's last update on 25 Nov 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 Hong Kong. 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?

Yes. Results are posted in the registry (first posted 25 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Duration of Laparoscopic Ovarian Cystectomy (time frame: duration of operation, up to 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02775344, which also lists 7 linked publications.

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 25 Nov 2019.

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