3D Versus 2D Laparoscopic Ovarian Cystectomy

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775344
• Other study ID #: UW 14-096
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: August 2016

Study information

• Verified date: November 2019
• Source: Queen Mary Hospital, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Device:
• Three dimension laparoscopy
Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy.

Locations

Country	Name	City	State
Hong Kong	Department of Obstetrics and Gynaecology, Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (7)

Bilgen K, Ustün M, Karakahya M, Isik S, Sengül S, Cetinkünar S, Küçükpinar TH. Comparison of 3D imaging and 2D imaging for performance time of laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2013 Apr;23(2):180-3. doi: 10.1097/SLE.0b013e3 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	duration of operation, up to 120 minutes
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.	During the operation, up to 120 minutes
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.	during the operation, up to 120 minutes
Secondary	Preference of Surgeons	Surgeons need to indicate their preference of 3D or 2D laparoscopy after the surgery.	during the operation, up to 120 minutes
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.	during the operation, up to 120 minutes
Secondary	Total Blood Loss During Operation	The total amount of blood loss during operation was recorded.	during the operation, up to 120 minutes
Secondary	Duration of Hospital Stay	The total duration of hospital stay was recorded.	Postoperative up to 6 weeks