Endpoint | Definition | Time point |
Perioperative endpoints | ||
Operative time | Minutes | Day of operation |
Intraoperative blood loss | Millilitres | Day of operation |
Conversion rate | Conversion to open surgery after starting minimally-invasive surgery | Day of operation |
For oncological patients | ||
Resection rate | R0/R1 resection38 | Day of operation |
Resected lymph nodes | According to pathologist | Day of operation |
Positive lymph nodes | According to pathologist | Day of operation |
Postoperative endpoints | ||
Pancreas-associated morbidity within 3 months | ||
Pancreatic fistula | According to updated ISGPS definition39 | Within 3 months after index operation |
Delayed gastric emptying | According to ISGPS definition5 | Within 3 months after index operation |
Postoperative haemorrhage | According to ISGPS definition3 | Within 3 months after index operation |
Intra-abdominal fluid collection | Any other fluid not covered by the above endpoints | Within 3 months after index operation |
Surgical site infection | According to CDC definition6 | Within 3 months after index operation |
ICU stay | Days | Until discharge |
Pain | Numeric Rating Scale | Until POD 14/discharge |
Mobility | Hours out of bed per day | Until POD 14/discharge |
Length of hospital stay | Days from the day of index operation | Until discharge |
Time to functional recovery | In days26 40; | Until discharge |
Defined as all of the following: | ||
Independently mobile at the preoperative level, | ||
Sufficient pain control with oral medication alone, | ||
Ability to maintain sufficient (ie, >50%) daily required caloric intake, | ||
No intravenous fluid administration, | ||
No signs of infection | ||
Case costs | Euros according to the German Diagnosis Related Group (DRG) system | Until discharge |
Long term secondary endpoints | ||
Endpoint | Definition | Timepoint |
Reintervention rate | Any intervention after index operation, for example, CT-guided drainage or endoscopy | Until 24 months after index operation |
Reoperation rate | Any reoperation after index operation | Until 24 months after index operation |
Quality of life | EORTC QLQ-C3041 for all patients; additionally, PAN 28 (CP) for patients with CP41 | Until 24 months after index operation |
Incisional hernia rate | Clinically or radiologically | Until 24 months after index operation |
Time to return to work or normal daily activities | Days | Within 24 months after index operation |
Overall survival | Rate of oncological patients alive | 24 months after index operation |
CP, chronic pancreatitis.