3D Versus 2D Laparoscopic Ovarian Cystectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Three-dimension Versus Two-dimension Laparoscopic Ovarian Cystectomy

Conditions
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Surgical Procedure, Unspecified

Intervention / Treatment
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* Device: Three dimension laparoscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during the operation, up to 120 minutes | 
| Preference of Surgeons | 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 | 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 | The total amount of blood loss during operation was recorded. | during the operation, up to 120 minutes | 
| Duration of Hospital Stay | The total duration of hospital stay was recorded. | Postoperative up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, ovarian cystectomy, three dimension laparoscopy