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Table 2 Secondary endpoint: definitions

From: Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711]

Event Definition
Pancreaticocutaneous fistula Pancreaticocutaneous fistula is defined as output, through a percutaneous drain, drainage canal after removal of drains, or from a surgical wound, of any measurable volume of fluid with an amylase content > 3 times the serum amylase level
Pancreatic insufficiency • Exocrine insufficiency is defined as an abnormal fecal elastase test or the need for oral pancreatic-enzyme supplementation to treat clinical symptoms of steatorrhea (not present before onset pancreatitis)
• Endocrine insufficiency is defined as insulin or oral antidiabetic drugs required (not present before onset pancreatitis)
Wound infection [9] Wound infection is defined as a superficial incisional surgical site infection (SSI) and must meet the following criterion:
Infection occurs within 30 days after the operative procedure and involves only skin and subcutaneous tissue of the incision and the patient has at least 1 of the following:
­purulent drainage from the superficial/deep incision but not from the organ/space component of the surgical site
­organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
­at least 1 of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat
­the superficial incision is deliberately opened by surgeon and is culture positive or not cultured. A culture-negative finding does not meet this criterion
­an abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination
­diagnosis of superficial/deep incisional SSI by the surgeon or attending physician