Surgical Procedure, Unspecified
Conditions
Keywords
Laparoscopy, ovarian cystectomy, three dimension laparoscopy
Brief summary
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
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.
Interventions
DEVICEThree dimension laparoscopy
Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy.
Sponsors
Queen Mary Hospital, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Duration of Laparoscopic Ovarian Cystectomy | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Need for Change of Instrument | 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. |
| Number of Surgeons Encountered Side Effects | 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. |
| Duration of Hospital Stay | Postoperative up to 6 weeks | The total duration of hospital stay was recorded. |
| Total Blood Loss During Operation | during the operation, up to 120 minutes | The total amount of blood loss during operation was recorded. |
| Preference of Surgeons | during the operation, up to 120 minutes | Surgeons need to indicate their preference of 3D or 2D laparoscopy after the surgery. |
Countries
Hong Kong
Participant flow
Pre-assignment details
3 women have been enrolled into the study with informed consent signed. However, their operations were rescheduled, thus did not include in the randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Three dimension laparoscopy: Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy. | 37 |
| Two Dimension Laparoscopy Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner. | 38 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No ovarian cyst identified | 3 | 2 |
Baseline characteristics
| Characteristic | Three Dimension Laparoscopy | Two Dimension Laparoscopy | Total |
|---|---|---|---|
| Age, Continuous | 35.6 years STANDARD_DEVIATION 7 | 36.6 years STANDARD_DEVIATION 7.1 | 36.1 years STANDARD_DEVIATION 7.1 |
| body mass index | 21.3 kg/m2 STANDARD_DEVIATION 2.6 | 23.4 kg/m2 STANDARD_DEVIATION 4.4 | 22.4 kg/m2 STANDARD_DEVIATION 3.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Hong Kong | 37 Participants | 38 Participants | 75 Participants |
| Sex: Female, Male Female | 37 Participants | 38 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 38 |
| other Total, other adverse events | 0 / 37 | 0 / 38 |
| serious Total, serious adverse events | 0 / 37 | 0 / 38 |
Outcome results
Primary
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.
Time frame: During the operation, up to 120 minutes
Population: Chief surgeons of the operation were required to find in a questionnaire immediate postoperatively which include GOALS score assessment, any side effects experienced and their preferences for 2D/ 3D laparoscopy for the particular operation. As the assessment is on case to case basis, thus individual surgeons not recruited.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Three Dimension Laparoscopy | Global Rating Scale Component of the Intraoperative Assessment Tool (GOALS) Score | 20.1 score on a scale | Standard Deviation 3.3 |
| Two Dimension Laparoscopy | Global Rating Scale Component of the Intraoperative Assessment Tool (GOALS) Score | 20.8 score on a scale | Standard Deviation 3.9 |
p-value: 0.393Chi-squared, Corrected
Primary
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.
Time frame: duration of operation, up to 120 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Three Dimension Laparoscopy | The Duration of Laparoscopic Ovarian Cystectomy | 51.6 minutes | Standard Deviation 36.2 |
| Two Dimension Laparoscopy | The Duration of Laparoscopic Ovarian Cystectomy | 47.6 minutes | Standard Deviation 32 |
p-value: 0.198Chi-squared, Corrected
Secondary
Duration of Hospital Stay
The total duration of hospital stay was recorded.
Time frame: Postoperative up to 6 weeks
Population: Chief surgeons of the operation were required to find in a questionnaire immediate postoperatively which include GOALS score assessment, any side effects experienced and their preferences for 2D/ 3D laparoscopy for the particular operation. As the assessment is on case to case basis, thus individual surgeons not recruited.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Three Dimension Laparoscopy | Duration of Hospital Stay | 2.4 Days | Standard Deviation 1.3 |
| Two Dimension Laparoscopy | Duration of Hospital Stay | 2.6 Days | Standard Deviation 1.2 |
Secondary
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.
Time frame: during the operation, up to 120 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Three Dimension Laparoscopy | Need for Change of Instrument | 0 Participants |
| Two Dimension Laparoscopy | Need for Change of Instrument | 0 Participants |
Secondary
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.
Time frame: during the operation, up to 120 minutes
Population: Chief surgeons of the operation were required to find in a questionnaire immediate postoperatively which include GOALS score assessment, any side effects experienced and their preferences for 2D/ 3D laparoscopy for the particular operation. As the assessment is on case to case basis, thus individual surgeons not recruited.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Three Dimension Laparoscopy | Number of Surgeons Encountered Side Effects | 17 Participants |
| Two Dimension Laparoscopy | Number of Surgeons Encountered Side Effects | 2 Participants |
Secondary
Preference of Surgeons
Surgeons need to indicate their preference of 3D or 2D laparoscopy after the surgery.
Time frame: during the operation, up to 120 minutes
Population: Chief surgeons of the operation were required to find in a questionnaire immediate postoperatively which include GOALS score assessment, any side effects experienced and their preferences for 2D/ 3D laparoscopy for the particular operation. As the assessment is on case to case basis, thus individual surgeons not recruited.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Three Dimension Laparoscopy | Preference of Surgeons | Prefer 3D laparoscopy | 7 Participants |
| Three Dimension Laparoscopy | Preference of Surgeons | Prefer 2D laparoscopy | 16 Participants |
| Three Dimension Laparoscopy | Preference of Surgeons | No Preference | 14 Participants |
| Two Dimension Laparoscopy | Preference of Surgeons | Prefer 3D laparoscopy | 0 Participants |
| Two Dimension Laparoscopy | Preference of Surgeons | Prefer 2D laparoscopy | 9 Participants |
| Two Dimension Laparoscopy | Preference of Surgeons | No Preference | 29 Participants |
Secondary
Total Blood Loss During Operation
The total amount of blood loss during operation was recorded.
Time frame: during the operation, up to 120 minutes
Population: Chief surgeons of the operation were required to find in a questionnaire immediate postoperatively which include GOALS score assessment, any side effects experienced and their preferences for 2D/ 3D laparoscopy for the particular operation. As the assessment is on case to case basis, thus individual surgeons not recruited.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Three Dimension Laparoscopy | Total Blood Loss During Operation | 58.2 ml | Standard Deviation 56.2 |
| Two Dimension Laparoscopy | Total Blood Loss During Operation | 55.1 ml | Standard Deviation 64.8 |