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Impact of a European training program for robot pancreatoduodenectomy using a video databank, da Vinci® simulator and robot biotissue anastomoses on clinical outcomes (LEARNBOT): a pan-European prospective study

Impact of a European training program for robot pancreatoduodenectomy using a video databank, da Vinci® simulator and robot biotissue anastomoses on clinical outcomes (LEARNBOT): a pan-European prospective study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21721
Enrollment
400
Registered
2020-09-07
Start date
2020-09-08
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

Malignancy of the pancreatic head.

Interventions

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age equal or above 18 years - Indication for elective pancreatoduodenectomy because of a malignant, pre-malignant or symptomatic benign disease located in the pancreatic head, distal bile duct, duodenum or ampulla of Vater - The procedure can be performed both laparoscopically and open according to the local surgeon - Fit to undergo pancreatoduodenectomy according to the surgeon and anaesthetist

Exclusion criteria

Exclusion criteria: Pregnancy

Design outcomes

Primary

MeasureTime frame
Major complications claviendindo >III

Secondary

MeasureTime frame
CUSUM operative time (learning curve) and secondary outcomes also include the relation between the OSATS and modified Birkmeyer scores of the biotissue PJ and HJ with the actual POPF grade B/C and bile leak grade B/C14 and the relation between prior laparoscopic surgery and the OSATS and Birkmeyer scores of the biotissue PJ and HJ and with clinical Clavien-Dindo III or higher complications.

Contacts

Public ContactLeia Jones

Amsterdam UMC

L.r.jones@amsterdamumc.nl0654338491

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)