Timepoint | Study period | ||||||
---|---|---|---|---|---|---|---|
Staff members | −t1 | 0 | t1.1 | t1.2 | t2 | t3 | |
Activity/assessment | Screening and consent | Allocation | Surgery | Peritoneal flap | Day of discharge | 6-month follow-up | |
Enroll | |||||||
 Eligibility screening | SC | x |  |  |  |  |  |
 Informed consent | AD | x |  |  |  |  |  |
 Allocation | SC |  | x |  |  |  |  |
INT | |||||||
 Group A (PELYCAN) | OS |  |  | x | x |  |  |
 Group B (control) | OS |  |  | x |  |  |  |
Assessments | |||||||
 Pre-existing medical conditions | AD | x |  |  |  |  |  |
 Medication | AD | x |  |  |  | x |  |
 Abdominal ultrasound | AD | x |  |  |  | x |  |
 Quality of life (QLQ-C30, EORTC) | AD, PU | x |  |  |  |  | x |
 Lymphocele (symptomatic/asymptomatic) | WD, PU |  |  |  |  | x | x |
 Lymphocele symptoms | WD, PU |  |  |  |  | x | x |
 Lymphedema/erysipelas | PU |  |  |  |  |  | x |
 Rehospitalization | PU |  |  |  |  |  | x |