Learning curve inflection before 50-60 cases
ID
Bron
Verkorte titel
Aandoening
Malignancy of the pancreatic head.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Major complications: Clavien/Dindo grade >2
Achtergrond van het onderzoek
Background: Safe implementation of robotic pancreatoduodenectomy is essential and may be facilitated by multicenter training programs. Data on multicenter training programs for robotic pancreatoduodenectomy (RPD) are lacking. The aim of this study is to investigate outcomes and learning curves of a multicenter training program for RPD including biotissue drills and the first consecutive patients.
Methods: A multicenter training program in RPD is designed according to the UPMC method, which includes videos, virtual reality (VR) simulation exercises, biotissue drills, online RPD video-bank, and proctoring (March 2016-September 2019). Prospectively collected outcomes are evaluated for the trained centers including all consecutive RPDs performed including 90-day follow-up. Cumulative sum (CUSUM) analysis is performed to assess the learning curve. Operative videos are assessed using an objective structured assessment of technical skill.
Doel van het onderzoek
Learning curve inflection before 50-60 cases
Onderzoeksopzet
None
Onderzoeksproduct en/of interventie
Multicenter robotic pancreatoduodenectomy training program
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Pregnancy
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL8073 |
Ander register | METC Amsterdam UMC (AMC) : W17_129 # 17.149 |