Table 2.

Outcome data and effect measure specification

Primary	SSI within 90 days after surgery by the author’s discretion*
Secondary	All-cause mortality within the longest available follow-up
Exploratory	Survival within the longest available follow-up Serious adverse events defined by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for good clinical practice64 SSI monitored according to the Centers for Disease Control and Prevention criteria and specified as either superficial, deep, organ/space65 Respiratory insufficiency: defined as the need for respiratory assistance provided as ventilator therapy or non-invasive ventilation within 90 days after surgery Unplanned intensive care unit admission (not part of routine postoperative care) (days) Hospital readmissions within 90 days after surgery Anastomotic leakage as defined by the international study group of rectal cancer66 Total duration of hospitalisation, including readmissions related to the initial hospitalisation Any cardiovascular complication at any time after surgery Any pulmonary complications at any time after surgery Stroke at any time after surgery New or recurrent cancer diagnosis at any time after surgery Any further clinically relevant outcome reported in the individual participant data

*When patients are reoperated within follow-up for reasons other than surgical site infection, these cases will be excluded from the analysis based on loss to follow-up.

SSI, surgical site infection.