3D Versus 2D Laparoscopic Ovarian Cystectomy

November 4, 2019 updated by: Lui Man Wa, Queen Mary Hospital, Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Obstetrics and Gynaecology, Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: three dimension laparoscopy
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
Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy.
No Intervention: Two dimension laparoscopy
Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Duration of Laparoscopic Ovarian Cystectomy
Time Frame: duration of operation, up to 120 minutes
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
Time Frame: During the operation, up to 120 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Surgeons Encountered Side Effects
Time Frame: during the operation, up to 120 minutes
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.
during the operation, up to 120 minutes
Preference of Surgeons
Time Frame: during the operation, up to 120 minutes
Surgeons need to indicate their preference of 3D or 2D laparoscopy after the surgery.
during the operation, up to 120 minutes
Need for Change of Instrument
Time Frame: during the operation, up to 120 minutes
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.
during the operation, up to 120 minutes
Total Blood Loss During Operation
Time Frame: during the operation, up to 120 minutes
The total amount of blood loss during operation was recorded.
during the operation, up to 120 minutes
Duration of Hospital Stay
Time Frame: Postoperative up to 6 weeks
The total duration of hospital stay was recorded.
Postoperative up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary Hospital, Hong Kong

Investigators

  • Principal Investigator: Man Wa Lui, MBBS, Queen Mary Hospital, the University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UW 14-096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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