Surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine. The traditional loop ileostomy has recently be challenged by ileostomies in continuity, either the Santulli or the Bishop-Koop one, that both decompresses the proximal dilated bowel and allow intestine fluid to pass through the underlying ileal anastomosis. Nevertheless, to date, no evaluation of their indications, complications and potential benefits has been made. The aim of this study is to retrospectively compare the outcomes of loop ileostomies and ileostomies in continuity in a paediatric population. It is thus expected to better define the specific indications for these different types of ileostomies in the paediatric and neonatal population.
The methodology used will be a retrospective non interventional study of the cohorts of paediatric patients having had one or more ileostomies performed in one of the surgical centers participating in this study, between 2007, january the 1st and 2019, august the 31th. The main outcome will be the duration (days) between full refunctionalization of the bowel in the groups of conventional ileostomy or ostomy in continuity, as assessed by the end of parenteral nutrition or the closure of the stoma. Secondary outcomes will include (1) the number and type of complications directly related to the stoma and/or to intestinal complications; (2) the comparison of the results obtained by Santulli and Bishop-Koop ileostomies; (3) a sub-group analysis of the outcomes in the different underlying pathologies.
Study Type
OBSERVATIONAL
Enrollment
300
Use of an ileostomy to decompress the proximal bowel, perfored either as a conventional loop ileostomy or as described by Santulli et al. or by Bishop and Koop.
University Hospital of Brest
Brest, France
University Hospital of Nantes
Nantes, France
Necker Enfants Malades Hospital
Paris, France
University Hospital of Rennes
Rennes, France
University Hospital of Tours
Tours, France
Delay before full refunctionalization of the small intestine
Mean delay before full enteral nutrition after the creation of the ileostomy, as assessed by either the end of the use of parenteral nutrition, or by closure of the ileostomy.
Time frame: through study completion, an average of 6 months
Clinical description of the sub-groups of patients with ostomy in continuity
Clinical description of the patients (underlying disease, demographics, nutritional outcomes, medical and surgical complications) having had a Santulli or a Bishop-Koop ostomy.
Time frame: through study completion, an average of 6 months
Comparative analysis of the complications of ostomies
Number and type of complications encountered after loop ileostomy and after ostomy in continuity
Time frame: through study completion, an average of 6 months
Subgroup analysis of the patients according to their underlying pathology
Comparative analysis of the efficacy and complication rates of the different types of stoma in subgroups of patients, according to their underlying pathology
Time frame: through study completion, an average of 6 months
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