3D Versus 2D Laparoscopic Ovarian Cystectomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-08-31

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.

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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.

Conditions

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Surgical Procedure, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Three dimension laparoscopy

Intervention Type DEVICE

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

Two dimension laparoscopy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Three dimension laparoscopy

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

Intervention Type DEVICE

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