No registrations found.
ID
Source
Brief title
Health condition
Not applicable: Setting is experimental.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint will be the time required to complete both PJ and HJ.
Secondary outcome
Secondary endpoint will be the objective structured assessment of technical skill (OSATS; range 12-60) rating; which will be scored by three observers blinded to 3D/2D.
Background summary
The aim of this study is to determine the added value of 3D-vision, as compared to 2D-vision, when performing PJ and HJ using the da Vinci® robotic system.
Consensus is lacking on the added value of 3D-vision during laparoscopic surgery. Given the improved dexterity with articulating instruments in robotic surgery, the added value of 3D-vision in robotic surgery is unclear.
We will test the added value of 3D-vision on procedure time and surgical performance during robotic biotissue pancreaticojejunostomy (PJ) and hepaticojejunostomy (HJ) as created during robotic pancreatoduodenectomy.
The setting will be experimental.
Study objective
3D-vision during robotic PJ and HJ biotissue anastomoses will reduce procedure time and improve surgical performance as compared to 2D-vision.
Study design
Not applicable.
Intervention
Participants will perform robotic PJ and HJ anastomoses in a biotissue organ model using the da Vinci® system and will be randomized to start with either 3D- or 2D-vision.
Inclusion criteria
Surgeons who are capable of robot-assisted suturing. Experience with minimally invasive pancreatoduodenectomy is not required.
Exclusion criteria
< 18 years
Participants (n = 0) will be excluded if they have no 3D-vision abilities, <200 seconds of arc ((assessed using a Randot Test (Stereo optical, Chicago, IL, USA).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8063 |
| Other | METC AMC : W17_066 # 17.084 |
Summary results
LAELAPS-2