Adverse event reporting and harms {22}
hematomas, seromas
HEMATOMAS, ADVERSE EVENTS, POSTOPERATIVE COMPLICATION, SECONDARY, ADVERSE EVENT, SITE INFECTION, SEROMAS, DER, COMPLICATIONS
Since trial interventions in P.E.L.I.O.N are medical routine, and the trial is conducted under the Medical Association’s professional code (Berufsordnung der Bundesärztekammer) §15, there is no need to record every adverse event. Instead of documenting serious adverse events (SAE), the following secondary endpoints will be used to assess safety in the P.E.L.I.O.N trial:Postoperative complications within 30 days according to the Dindo-Clavien classification (DCC) ≥3 [Superficial or deep surgical site infections (SSIs) within 1 year after index operation according to the CDC definition [Rate of wound seromas at former ostomy site within 30 days after the index operationRate of hematomas at former ostomy site within 30 days after the index operationEnterocutaneous fistulas within 24 months after the index operation [Number of revision surgeries because of complications related to ileostomy closure within 24 months after the index operation