3D Versus 2D Laparoscopic Ovarian Cystectomy

• Sponsor: Queen Mary Hospital, Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT02775344
• Collaborator: (none)
• Enrollment: 83
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Procedure, Unspecified	Device: Three dimension laparoscopy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Three-dimension Versus Two-dimension Laparoscopic Ovarian Cystectomy
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Three dimension laparoscopy; Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy.
No Intervention: Two dimension laparoscopy Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. Preference of Surgeons [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 [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 [during the operation, up to 120 minutes]

   The total amount of blood loss during operation was recorded.

5. Duration of Hospital Stay [Postoperative up to 6 weeks]

   The total duration of hospital stay was recorded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynaecology, Queen Mary Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

• Queen Mary Hospital, Hong Kong

Investigators

• Principal Investigator: Man Wa Lui, MBBS, Queen Mary Hospital, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cicione A, Autorino R, Breda A, De Sio M, Damiano R, Fusco F, Greco F, Carvalho-Dias E, Mota P, Nogueira C, Pinho P, Mirone V, Correia-Pinto J, Rassweiler J, Lima E. Three-dimensional vs standard laparoscopy: comparative assessment using a validated program for laparoscopic urologic skills. Urology. 2013 Dec;82(6):1444-50. doi: 10.1016/j.urology.2013.07.047. Epub 2013 Oct 2.
• Lusch A, Bucur PL, Menhadji AD, Okhunov Z, Liss MA, Perez-Lanzac A, McDougall EM, Landman J. Evaluation of the impact of three-dimensional vision on laparoscopic performance. J Endourol. 2014 Feb;28(2):261-6. doi: 10.1089/end.2013.0344. Epub 2014 Jan 10.
• Storz P, Buess GF, Kunert W, Kirschniak A. 3D HD versus 2D HD: surgical task efficiency in standardised phantom tasks. Surg Endosc. 2012 May;26(5):1454-60. doi: 10.1007/s00464-011-2055-9. Epub 2011 Dec 17.
• Tanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the fundamentals of laparoscopic surgery skill set. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):865-70. doi: 10.1089/lap.2012.0220. Epub 2012 Oct 16.
• Vassiliou MC, Feldman LS, Andrew CG, Bergman S, Leffondré K, Stanbridge D, Fried GM. A global assessment tool for evaluation of intraoperative laparoscopic skills. Am J Surg. 2005 Jul;190(1):107-13.
• Wagner OJ, Hagen M, Kurmann A, Horgan S, Candinas D, Vorburger SA. Three-dimensional vision enhances task performance independently of the surgical method. Surg Endosc. 2012 Oct;26(10):2961-8. Epub 2012 May 12.

• Responsible Party: Lui Man Wa, Dr, Queen Mary Hospital, Hong Kong
• ClinicalTrials.gov Identifier: NCT02775344
• Other Study ID Numbers: UW 14-096
• First Posted: May 17, 2016
• Last Update Posted: Nov 25, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Lui Man Wa, Dr, Queen Mary Hospital, Hong Kong: Laparoscopy; ovarian cystectomy; three dimension laparoscopy

Study Results

Participant Flow

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

Arm/Group Title	Three Dimension Laparoscopy	Two Dimension Laparoscopy
Arm/Group Description	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 laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Period Title: Overall Study
STARTED	40	40
COMPLETED	37	38
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Three Dimension Laparoscopy	Two Dimension Laparoscopy	Total
Arm/Group Description	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 laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.	Total of all reporting groups
Overall Participants	37	38	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.6 (7.0)	36.6 (7.1)	36.1 (7.1)
Sex: Female, Male (Count of Participants)
Female	37 100%	38 100%	75 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Hong Kong	37 100%	38 100%	75 100%
body mass index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	21.3 (2.6)	23.4 (4.4)	22.4 (3.8)

Outcome Measures

1. Primary Outcome

Title	The Duration of Laparoscopic Ovarian Cystectomy
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Three Dimension Laparoscopy	Two Dimension Laparoscopy
Arm/Group Description	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 laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Measure Participants	37	38
Mean (Standard Deviation) [minutes]	51.6 (36.2)	47.6 (32.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Three Dimension Laparoscopy, Two Dimension Laparoscopy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.198
	Comments
	Method	Chi-squared, Corrected
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Three Dimension Laparoscopy	Two Dimension Laparoscopy
Arm/Group Description	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 laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Measure Participants	37	38
Mean (Standard Deviation) [score on a scale]	20.1 (3.3)	20.8 (3.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Three Dimension Laparoscopy, Two Dimension Laparoscopy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.393
	Comments
	Method	Chi-squared, Corrected
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.7
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Surgeons Encountered Side Effects
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Three Dimension Laparoscopy	Two Dimension Laparoscopy
Arm/Group Description	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 laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Measure Participants	37	38
Count of Participants [Participants]	17 45.9%	2 5.3%

4. Secondary Outcome

Title	Preference of Surgeons
Description	Surgeons need to indicate their preference of 3D or 2D laparoscopy after the surgery.
Time Frame	during the operation, up to 120 minutes

Outcome Measure Data

Analysis Population Description

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/Group Title	Three Dimension Laparoscopy	Two Dimension Laparoscopy
Arm/Group Description	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 laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Measure Participants	37	38
Prefer 3D laparoscopy	7 18.9%	0 0%
Prefer 2D laparoscopy	16 43.2%	9 23.7%
No Preference	14 37.8%	29 76.3%

5. Secondary Outcome

Title	Need for Change of Instrument
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Three Dimension Laparoscopy	Two Dimension Laparoscopy
Arm/Group Description	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 laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Measure Participants	37	38
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Total Blood Loss During Operation
Description	The total amount of blood loss during operation was recorded.
Time Frame	during the operation, up to 120 minutes

Outcome Measure Data

Analysis Population Description

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/Group Title	Three Dimension Laparoscopy	Two Dimension Laparoscopy
Arm/Group Description	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 laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Measure Participants	37	38
Mean (Standard Deviation) [ml]	58.2 (56.2)	55.1 (64.8)

7. Secondary Outcome

Title	Duration of Hospital Stay
Description	The total duration of hospital stay was recorded.
Time Frame	Postoperative up to 6 weeks

Outcome Measure Data

Analysis Population Description

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/Group Title	Three Dimension Laparoscopy	Two Dimension Laparoscopy
Arm/Group Description	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 laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
Measure Participants	37	38
Mean (Standard Deviation) [Days]	2.4 (1.3)	2.6 (1.2)

Adverse Events

Time Frame	2 months
Arm/Group Title	Three Dimension Laparoscopy		Two Dimension Laparoscopy
Arm/Group Description	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 laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.
All Cause Mortality
	Three Dimension Laparoscopy		Two Dimension Laparoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/38 (0%)
Serious Adverse Events
	Three Dimension Laparoscopy		Two Dimension Laparoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Three Dimension Laparoscopy		Two Dimension Laparoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/38 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.