No registrations found.
ID
Source
Brief title
Health condition
Malignancy of the pancreatic head.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Major complications claviendindo >III
Secondary outcome
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.
Background summary
Robot pancreatoduodenectomy (RPD) aims to minimize the impact of this extensive surgical procedure and enhance patient recovery. Many large European pancreatic centers are currently considering to start with a da Vinci® pancreatoduodenectomy program but a European training program is lacking. We have set up a European training program for RPD. This study aims to determine the impact of a European training program for robot pancreatoduodenectomy using video, da Vinci® simulator and biotissue anastomoses on the learning curve and clinical outcomes as registered in the ongoing European E-MIPS registry on minimally invasive pancreatic surgery. As a secondary objective the impact of previous laparoscopic experience will be assessed.
Study objective
Learning curve inflection before 50-60 cases
Study design
For the primary outcome: The first 20 RPD procedures after the LEARNBOT training are recorded and these videos will be reviewed. Data from all RPD procedures after the training program will be registered in the E-MIPS registry for at least 36 months. Outcomes are registered using the European E-MIPS registry, this is an online database.
For secondary outcomes: The robot biotissue HJ and PJ anastomoses will be recorded and analyzed using Apple video software, final cut pro. The procedure length and quality will be scored using the Birkmeyer surgical performance grading. Videos of each anastomosis are edited and will be sent to 2 blinded graders. The videos are scored based on the objective structured assessment of technical skills (OSATS) for identification of learning curves, validated by Hogg, et al., and Birkmeyer. Additional procedure specific scoring systems will be developed and used for evaluations in the future. For outcomes of the RPD procedures we will use the E-MIPS registry.
Intervention
Multicenter robotic pancreatoduodenectomy training program
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
Pregnancy
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 | NL8898 |
| Other | METC Amsterdam UMC (AMC) : W20_137 # 20.176 |