NCT02775344

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

November 25, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

May 12, 2016

Results QC Date

September 23, 2019

Last Update Submit

November 4, 2019

Conditions

Surgical Procedure, Unspecified

Keywords

Laparoscopyovarian cystectomythree dimension laparoscopy

Outcome Measures

Primary Outcomes (2)

  • 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.

    duration of operation, up to 120 minutes

  • 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.

    During the operation, up to 120 minutes

Secondary Outcomes (5)

  • Number of Surgeons Encountered Side Effects

    during the operation, up to 120 minutes

  • Preference of Surgeons

    during the operation, up to 120 minutes

  • Need for Change of Instrument

    during the operation, up to 120 minutes

  • Total Blood Loss During Operation

    during the operation, up to 120 minutes

  • Duration of Hospital Stay

    Postoperative up to 6 weeks

Study Arms (2)

three dimension laparoscopy

EXPERIMENTAL

This group of patients will have laparoscopic ovarian cystectomy performed using three-dimension laparoscopy. The procedure will be performed in usual manner.

Device: Three dimension laparoscopy

Two dimension laparoscopy

NO INTERVENTION

Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.

Interventions

Three dimension laparoscopyDEVICE

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

three dimension laparoscopy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynaecology, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (7)

  • 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.

    PMID: 22179446BACKGROUND

  • 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.

    PMID: 24059674BACKGROUND

  • 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.

    PMID: 23072406BACKGROUND

  • 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.

    PMID: 22580874BACKGROUND

  • 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.

    PMID: 24094658BACKGROUND

  • 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.

    PMID: 15972181BACKGROUND

  • 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.

    PMID: 23579515RESULT

Results Point of Contact

Title
Dr Manwa Lui
Organization
Queen Mary Hospital
ellenlui@hku.hk
22554647

Study Officials

  • Man Wa Lui, MBBS

    Queen Mary Hospital, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 17, 2016

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

November 25, 2019

Results First Posted

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)