Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Ileostomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ileostomy in continuity<br>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. | Procedure: Ileostomy<br>* 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.<br>* Other names: Bishop-Koop ileostomy;|
| Conventional ileostomy<br>Paediatric patients having had a loop ileostomy as part of the treatment for a complex intestinal obstruction. | Procedure: Ileostomy<br>* 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.<br>* Other names: Bishop-Koop ileostomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ileostomy, enteral nutrition, complications of stoma