Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis (StomaPed)

University Hospital, Angers

Status: Unknown

Conditions: Hirschsprung Disease; Gastroschisis; Enterocolitis, Necrotizing; Intestinal Obstruction

Treatments: Procedure: Ileostomy

Study type: Observational

Funder types: Other

Identifiers

NCT04213976

2019/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 1 minute to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patient aged 16 or less having had one or more ileostomy created as part of its care for an intestinal obstruction, between 2007/01/01 and 2019/08/31. If a patient requires more than one ileostomy, each new stoma will be analysed as a new entry in the study.
• patients having been operated in one of the paediatric surgical department participating in this study.

Exclusion criteria

• refusal or absence on consent of the patient and/or their legal representative to participate to the study.
• patient who had an ileostomy created in another center than the ones participating in the present study.

Trial design

300 participants in 2 patient groups

Ileostomy in continuity

Description:

Paediatric patients having had an ileostomy in continuity as part of the treatment for a complex intestinal obstruction, as described by Santulli or by Bishop-Koop.

Treatment:

Procedure: Ileostomy

Conventional ileostomy

Description:

Paediatric patients having had a loop ileostomy as part of the treatment for a complex intestinal obstruction.

Treatment:

Procedure: Ileostomy