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Table 2 Summary and definitions of secondary outcomes

From: ChroPac-Trial: Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial

Summary and definitions secondary outcomes
Mortality Death due to any cause at any time during the follow-up period including reason.
General morbidity  
▪ Wound infection Surgical site infections will be assessed at discharge and 6 months after surgery, divided into superficial and deep incisional surgical site infection according to the Center for Disease Control and Prevention definition [22].
▪ Pulmonary infection Post-Op-Pulmonary infection will be assessed, at discharge and 6 months and is defined according to local standards:
  Infection of the lung with either evidence of increased infection parameters (CRP > 2 mg/dl and/or leukocytes > 10 0000/ml) which are not caused by a different pathologic process or evidence of pulmonary infiltration in the chest x-ray, requiring antibiotic therapy.
Pancreas associated postoperative morbidity  
▪ Postoperative Pancreatic fistula [12] Any abnormal communication between the pancreatic ductal epithelium and another epithelial surface containing pancreas-derived, enzyme-rich fluid.
  It should satisfy the following criteria:
     • output through an operatively placed drain or a subsequently placed percutaneous drain of any measurable volume of drain fluid
     • on or after postoperative day 3
     • amylase content in fluid greater than three times the upper normal serum value.
  Since only longstanding observation will confirm the diagnosis, it is necessary to distinguish and to grade the POPF as grades A, B and C after clinical recovery is complete.
  Grade A:
     • Without clinical impact
     • Oral nutrition
     • No antibiotics
     • No somatostatin analogues
     • No peripancreatic fluid collection
     • No delay in hospital discharge
  Grade B:
     • Clinically relevant
     • Partial/total parenteral/enteral nutrition
     • Peripancreatic collection possible
     • Abdominal pain, fever, and/or leucocytosis possible
     • Antibiotics and somatostatin analogues may be necessary
     • Delay in hospital discharge or readmission may be required
  Grade C:
     • Clinical stability maybe borderline
     • Treatment in an intensive care unit in many cases
     • Total parenteral/enteral nutrition
     • Intravenous antibiotics and somatostatin analogues necessary
     • Worrisome peripancreatic fluid collection that requires percutaneous drainage
     • Extended hospital stay
     • Often associated complications and postoperative mortality possible
▪ Delayed gastric emptying [13] Delayed gastric emptying represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A, B, and C) were defined based on the impact of the clinical course and on postoperative management.
Operation time From skin incision to closure of wound [min].
Blood loss assessed by surgeons and anesthesists Intraoperative blood loss [ml].
Hospital stay  
▪ Initial postoperative hospital stay after randomization Day of operation until day of discharge.
▪ Total hospital stay due to chronic pancreatitis within 24 months after randomization Total amount of hospital days after randomization for any treatment due to chronic pancreatitis within 24 months.
Reoperation due to recurrence of chronic pancreatitis Any surgical intervention for treatment of the pancreas at any time during the follow-up period.
Weight gain Body weight [kg] assessed at all visits.
New onset of diabetes mellitus requiring treatment Any continuous treatment (drugs) of diabetes lasting for 12 months.
Development of exocrine insufficiency (continuous supplement of pancreatic enzymes necessary) Any continuous treatment (drugs) of exocrine insufficiency lasting for 12 months.