Trial Outcomes & Findings for 3D Versus 2D Laparoscopic Ovarian Cystectomy (NCT NCT02775344)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

83 participants

Primary outcome timeframe

duration of operation, up to 120 minutes

Results posted on

2019-11-25

Participant Flow

3 women have been enrolled into the study with informed consent signed. However, their operations were rescheduled, thus did not include in the randomization.

Participant milestones

Participant milestones
Measure	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.	Two Dimension Laparoscopy Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Overall Study STARTED	40	40
Overall Study COMPLETED	37	38
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Two Dimension Laparoscopy Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Overall Study No ovarian cyst identified	3	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Three Dimension Laparoscopy n=37 Participants 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.	Two Dimension Laparoscopy n=38 Participants Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.	Total n=75 Participants Total of all reporting groups
Age, Continuous	35.6 years STANDARD_DEVIATION 7.0 • n=37 Participants	36.6 years STANDARD_DEVIATION 7.1 • n=38 Participants	36.1 years STANDARD_DEVIATION 7.1 • n=75 Participants
Sex: Female, Male Female	37 Participants n=37 Participants	38 Participants n=38 Participants	75 Participants n=75 Participants
Sex: Female, Male Male	0 Participants n=37 Participants	0 Participants n=38 Participants	0 Participants n=75 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Hong Kong	37 Participants n=37 Participants	38 Participants n=38 Participants	75 Participants n=75 Participants
body mass index	21.3 kg/m2 STANDARD_DEVIATION 2.6 • n=37 Participants	23.4 kg/m2 STANDARD_DEVIATION 4.4 • n=38 Participants	22.4 kg/m2 STANDARD_DEVIATION 3.8 • n=75 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Three Dimension Laparoscopy n=37 Participants 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.	Two Dimension Laparoscopy n=38 Participants Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
The Duration of Laparoscopic Ovarian Cystectomy	51.6 minutes Standard Deviation 36.2	47.6 minutes Standard Deviation 32.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Three Dimension Laparoscopy n=37 Participants 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.	Two Dimension Laparoscopy n=38 Participants Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Global Rating Scale Component of the Intraoperative Assessment Tool (GOALS) Score	20.1 score on a scale Standard Deviation 3.3	20.8 score on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Three Dimension Laparoscopy n=37 Participants 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.	Two Dimension Laparoscopy n=38 Participants Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Number of Surgeons Encountered Side Effects	17 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

Surgeons need to indicate their preference of 3D or 2D laparoscopy after the surgery.

Outcome measures

Outcome measures
Measure	Three Dimension Laparoscopy n=37 Participants 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.	Two Dimension Laparoscopy n=38 Participants Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Preference of Surgeons Prefer 2D laparoscopy	16 Participants	9 Participants
Preference of Surgeons No Preference	14 Participants	29 Participants
Preference of Surgeons Prefer 3D laparoscopy	7 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Three Dimension Laparoscopy n=37 Participants 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.	Two Dimension Laparoscopy n=38 Participants Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Need for Change of Instrument	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

The total amount of blood loss during operation was recorded.

Outcome measures

Outcome measures
Measure	Three Dimension Laparoscopy n=37 Participants 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.	Two Dimension Laparoscopy n=38 Participants Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Total Blood Loss During Operation	58.2 ml Standard Deviation 56.2	55.1 ml Standard Deviation 64.8

SECONDARY outcome

Timeframe: 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.

The total duration of hospital stay was recorded.

Outcome measures

Outcome measures
Measure	Three Dimension Laparoscopy n=37 Participants 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.	Two Dimension Laparoscopy n=38 Participants Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Duration of Hospital Stay	2.4 Days Standard Deviation 1.3	2.6 Days Standard Deviation 1.2

Adverse Events

Three Dimension Laparoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Two Dimension Laparoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Manwa Lui

Queen Mary Hospital

Phone: 22554647

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place