Inclusion/exclusion criteria
traumatic injury, Sepsis, bleeding, peritonitis, purulent, pancreatitis, septic shock, stoma, viscus, feculent, IAH/ACS
PERITONEAL CARCINOMATOSIS, SEPSIS, BLEEDING, PERITONITIS, SUPERIOR MESENTERIC ARTERY OCCLUSION, CAVITY, PANCREATITIS, SEPTIC SHOCK, PATHOLOGY, SPILLAGE
Potential patients will first be identified in the emergency departments, in-patient ward, and critical care units of the participating centers. Eligibility can only be completely determined after the abdomen is explored in the operating room during the conduct of a laparotomy for source control. Patients will be eligible for inclusion if they have SCIAS, as operationally defined by the COOL trial (Fig. Inclusion criteria for COOLThe inclusion criteria are conceptually a two-part assessment to ascertain if patients clearly fulfill the definition of both severe and complicated IAS (SCIAS) while undergoing source control laparotomy. Thus, during the laparotomy it will become apparent to the operating surgical team that peritonitis is complicated, which will be reproducibly demonstrated by uncontained or unconfined purulent, feculent, or enteric spillage. In addition to being complicated, the inclusion criteria require that patients have severe IAS. For the purpose of the COOL trial, severe will be defined by any of: septic shock as defined by Sepsis 3 Consensus Guidelines [The exclusion criteria for the COOL trial include: a) pregnancy, b) perceived physical inability to physically close the fascia primarily without undue tension or concerns for inducing severe IAH/ACS, c) intra-operatively determined absolute or relative requirement for “damage control” laparotomy including intraperitoneal packing or non-anatomic postsurgical anatomy (i.e., surgically placed permanent packing or bowel that the operating surgeon believes must be left in discontinuity after resection), d) the patient is expected to die shortly after operation because of their condition in the operating room and there is no intention of providing ongoing care (i.e., the treating team wishes to close the abdomen to leave the operating room with the sole intention of withdrawing aggressive measures and providing only “comfort care” in the ICU; an example of where this could occur would be complete transmural midgut ischemia/necrosis), e) laparoscopic surgery (no laparotomy), f) pancreatitis as the source of peritonitis, g) acute superior mesenteric artery occlusion as the primary pathology, h) co-enrollment in another investigational study, i) peritoneal carcinomatosis, j) traumatic injury within 24 h of the development of SCIAS, k) age < 18, or l) uncontrolled bleeding. It will be important for surgeons considering recruiting a patient to recognize before enrolling and randomizing a patient that fascial closure is not possible, as recognizing this after allocation to closure will constitute a protocol violation.In current practice, it is likely that the most common reason for non-eligibility will be a surgeon-based decision to resect a hollow viscus and due to the perceived critical nature of the patient decide not to re-anastomose the bowel but to instead perform damage control and return the bowel ends into the peritoneal cavity without a diverting stoma. As this is an absolute indication for a future reoperation these patients will be ineligible for randomization.