226 Chapter 10 Data extraction Baseline characteristics and complications are presented for all patients. Diseases with N<10 were included as “Other” and are specified in supplementary Table 1. The primary outcome included the incidence of major stoma related morbidity, which was defined as Clavien-Dindo grade ≥III complications (morbidity that led to redosurgery, intensive care admission or death).[12] Non-stoma related morbidity and stoma related complications with a Clavien-Dindo grade I or II were excluded. Patients that died within 30 days following formation or closure to non-stoma related causes were excluded from the analysis. Stoma related morbidity included: central line sepsis, high output stoma, stoma prolapse, stoma necrosis, stoma stenosis, adhesive obstruction, parastomal hernia, fistula to stoma and anastomotic leakage. Furthermore, following stoma closure, any morbidity related to the initial stoma site which resulted in surgery (e.g. correction of scar tissue or abscess drainage under general anaesthesia) was included.[12] Major stoma related morbidity was noted for both types of stoma interventions (formation and closure) and classified according to the moment of occurrence following surgery (within 30 days or after 30 days). Patients with a high-output stoma were only included if they underwent redo surgery for insertion of a central venous line. Central line sepsis was only included if the blood culture was positive in concordance with clinical suspicion which led to replacement of a new central venous line under general anaesthesia or admission to the intensive care. Adhesive obstructions were identified based on the combined information from the electronic patient file, and surgical and radiological reports, and were recorded only if leading to redo surgery. In case of uncertainty based on the reports, a paediatric surgeon (JD) was consulted. Parastomal hernias were included based on physical examination or ultrasound results and the need for a re-intervention. For anastomotic leakage, the definition and classification of the International Study Group of Rectal Cancer (ISREC) was used.[13, 14] There is no consensus on a definition for anastomotic stenosis. For this reason, anastomotic stenosis was presumed in patients with obstructive symptoms and description of a stenosis at the anastomotic site seen on contrast enema or during surgery. To distinguish anastomotic stenosis from post disease strictures in necrotizing enterocolitis, an anastomotic stenosis was only included if the stenosis was described at the site of the anastomosis in the surgical report. Risk factors for the overall occurrence of major stoma related morbidity (any patient who experienced one or more high grade complications either during or after 30 days) were analysed following stoma formation and following stoma closure separately. Factors that were analysed included gender, surgery before stoma formation, underlying
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