2.8. Secondary endpoints:
tenderness, perforation, fever
SECONDARY, COMPLICATIONS
Several secondary endpoints will be evaluated. The first is the incidence of procedural complications (i.e., intraoperative perforation, delayed perforation, post-bleeding, PECS), defined as the ratio of the number of procedure-related complications to the total number of patients in the efficacy analysis population. PECS in the absence of obvious perforation will be defined as localized tenderness plus fever > 37.6°C, white blood cell count > 10.000/mmOther secondary endpoints will include the 