Added value of 3D-vision during robotic surgery in biotissue pancreatico- and hepaticojejunostomy (LAEBOT 3D2D): a randomized controlled cross-over trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25901

Enrollment

Registered

2019-10-02

Start date

2017-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not applicable: Setting is experimental.

Interventions

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.

Eligibility

Inclusion criteria

Inclusion criteria: Surgeons who are capable of robot-assisted suturing. Experience with minimally invasive pancreatoduodenectomy is not required.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Primary endpoint will be the time required to complete both PJ and HJ.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactLeia Jones

Amsterdam UMC

L.r.jones@amsterdamumc.nl0654338491

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)