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Table 1 Definition of secondary endpoints

From: One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial

Secondary endpoint

Definition and assessment of outcomes

Anastomosis time

Time from beginning to end of PJ anastomosis

Mortality

Death due to any cause until 90 days after the operation and the reason

Morbidity

Postoperative complications will be recorded until 90 days after operation. The severity of complications will be graded according to the Clavien-Dindo classification [18]

Postoperative hospital stay

Time from day of operation until discharge (days)

Postpancreatectomy hemorrhage

Evidence of blood loss from drains and/or nasogastric tube, based on ultrasonography, as defined by ISGPS [19]

Biliary leak

Bilirubin concentration in the drain fluid at least three times the serum bilirubin concentration as defined by International Study Group of Liver Surgery [20]

Delayed gastric emptying

Failure to resume solid diet with prolonged need for nasogastric tube as defined by ISGPS [21]

Intra-abdominal fluid collection

Collection of fluid measuring ≥3 cm associated with clinical or laboratory abnormalities

Wound infection

Surgical site infection associated with laparotomy that develops during the initial hospital stay

Pneumonia

Presence of a new infiltrate on chest X-ray, as well as following: body temperature >38 °C, abnormal elevation of white blood cells, or positive sputum, and requiring antibiotic treatment

Abdominal rupture

Dehiscence of abnormal closure with need for resuture of the laparotomy during the initial hospital stay