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ClinicalTrials.gov ID

NCT04213976

Lead Sponsor

University Hospital, AngersOTHER_GOV

Overall Status

Unknown status

Study Type

Observational

Enrollment

300Estimated

Last Update Posted

Dec 30, 2019Actual

Start Date

Jan 1, 2020Estimated

Primary Completion Date

Jun 30, 2020Estimated

Completion Date

Dec 31, 2020Estimated

Official Title

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

Brief 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.

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

• Ileostomy

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Retrospective

Lead Sponsor

University Hospital, AngersOTHER_GOV

sebastien.faraj@chu-nantes.fr

sabine.sarnacki@aphp.fr

alexis.arnaud@chu-rennes.fr

ibtissam.kassite@univ-tours.fr