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临床试验/NCT02775344
NCT02775344已完成不适用

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

Queen Mary Hospital, Hong Kong1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2014年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
试验地点
1
主要终点
The Duration of Laparoscopic Ovarian Cystectomy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Three dimension laparoscopy (Device)

Two dimension laparoscopy

No Intervention

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

结局指标

主要结局

The Duration of Laparoscopic Ovarian Cystectomy

时间窗: 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.

Global Rating Scale Component of the Intraoperative Assessment Tool (GOALS) Score

时间窗: 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.

次要结局

  • Need for Change of Instrument(during the operation, up to 120 minutes)
  • Number of Surgeons Encountered Side Effects(during the operation, up to 120 minutes)
  • Preference of Surgeons(during the operation, up to 120 minutes)
  • Duration of Hospital Stay(Postoperative up to 6 weeks)
  • Total Blood Loss During Operation(during the operation, up to 120 minutes)

研究者

发起方
Queen Mary Hospital, Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lui Man Wa

Dr

Queen Mary Hospital, Hong Kong

研究点 (1)

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