NCT04213976

Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis

Ostomy in Continuity or Conventional Ileostomy for Complex Pediatric Intestinal Diseases: a Retrospective Multicentric Analysis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 1 Minute – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Intestinal Obstruction
• Gastroschisis
• Enterocolitis, Necrotizing
• Hirschsprung Disease

Interventions

Type	Name	Description
PROCEDURE	Ileostomy	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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-06-30
• Completion: 2020-12-31
• First posted: 2019-12-30
• Last updated: 2019-12-30

Locations

5 sites across 1 country: France