Hirschsprung Disease Clinical Trial
Official title:
Ostomy in Continuity or Conventional Ileostomy for Complex Pediatric Intestinal Diseases: a Retrospective Multicentric Analysis
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.
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