Clinical outcomes
death, intra-abdominal hemorrhage, hernia, organ dysfunction, necrotic, organ failure, fistula, intra-abdominal bleeding, sepsis, biliary strictures
INTRA-ABDOMINAL BLEEDING, INTRA-ABDOMINAL HEMORRHAGE, NECROTIC, SECONDARY, PANCREATIC FISTULA, WOUND INFECTIONS, SEPSIS, COMPLICATIONS
To assess the efficacy of the combined VARTD and continuous postoperative lavage in the treatment of iWONde, we prespecified the primary efficacy endpoint as clinical improvement up to day 28 after the VARTD, which defined as a reduction of 75% or greater in size of necrotic collection (in any axis) on CT and clinical resolution of sepsis or organ dysfunction within the first 4 postoperative weeks. Baseline CECT-derived parameters were measured before the VARTD. Repeat CECT scan was performed routinely for a period of 7–14 days, or when less than 50 mL per day fluid drained was observed, or in case of clinical suspicion of enteral/pancreatic fistula or intra-abdominal bleeding. The secondary efficacy endpoint was reintervention on for an additional debridement/necrosectomy. The primary safety endpoint was a composite of major complications comprising enterocutaneous or pancreatic fistula, visceral perforation, and intra-abdominal hemorrhage that require intervention; new-onset organ failure; in-hospital death, and death within 6 months after discharge. The secondary safety endpoints included individual primary endpoint components, biliary strictures, incisional hernia, wound infections, pancreatic endocrine and exocrine insufficiency, and intensive care unit (ICU) and hospital length of stay after the VARTD. Definitions of the safety endpoints were consistent with previous reports [