Methods
COMPLICATIONS
Both studies were approved by national ethics boards initially, and a supplement to the primary ethics approval was sent in and approved (2021-06755-02) in Sweden and Norway. In the Netherlands, additional approval was not considered necessary by the Medical Ethics Review Committee of the Academic Medical Centre.Individualized data were retrieved from SCANDIV and the LOLA arm of the LADIES trial. All data were collected prospectively. The SCANDIV trial was designed as a pragmatic, two-armed, open-labelled, multicentre, superiority randomized trial. Patients were enrolled in 21 surgical units (9 in Sweden and 12 in Norway)Patients were evaluated on an intention-to-treat basis. All factors that may predict treatment failure, defined as complications of at least Clavien–Dindo grade IIIb (requiring general anaesthesia), were analysed