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Completed

NCT Number: NCT02775344

3D Versus 2D 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynaecology, Queen Mary Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Three dimension laparoscopy

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Total Blood Loss During Operation

    Time frame: during the operation, up to 120 minutes

    The total amount of blood loss during operation was recorded.

  5. Duration of Hospital Stay

    Time frame: Postoperative up to 6 weeks

    The total duration of hospital stay was recorded.

Sponsors and collaborators

Lead sponsor

Queen Mary Hospital, Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 17, 2016
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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