Clinical trial NCT04213976: Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis
Official title: Ostomy in Continuity or Conventional Ileostomy for Complex Pediatric Intestinal Diseases: a Retrospective Multicentric Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intestinal Obstruction
Gastroschisis
Enterocolitis, Necrotizing
Hirschsprung Disease
Keywords: ileostomy
enteral nutrition
complications of stoma
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-12-30
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns and children presenting with complex intestinal obstruction and requiring the use of an ileostomy to discharge the upper intestine as part of surgical care.

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.

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.

Primary outcomes:
measure: Delay before full refunctionalization of the small intestine
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Clinical description of the sub-groups of patients with ostomy in continuity
timeFrame: through study completion, an average of 6 months
measure: Comparative analysis of the complications of ostomies
timeFrame: through study completion, an average of 6 months
measure: Subgroup analysis of the patients according to their underlying pathology
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Brest
country: France
facility: University Hospital of Brest
city: Nantes
country: France
facility: University Hospital of Nantes
city: Paris
country: France
facility: Necker Enfants Malades Hospital
city: Rennes
country: France
facility: University Hospital of Rennes
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: University Hospital of Angers
name: Françoise Schmitt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: BISHOP HC, KOOP CE. Management of meconium ileus; resection, Roux-en-Y anastomosis and ileostomy irrigation with pancreatic enzymes. Ann Surg. 1957 Mar;145(3):410-4. doi: 10.1097/00000658-195703000-00017. No abstract available.
citation: SANTULLI TV, BLANC WA. Congenital atresia of the intestine: pathogenesis and treatment. Ann Surg. 1961 Dec;154(6):939-48. No abstract available.
citation: Sehgal S, Sandler AD, Alfred Chahine A, Mohan P, Torres C. Ostomy in continuity: A novel approach for the management of children with complex short bowel syndrome. J Pediatr Surg. 2018 Oct;53(10):1989-1995. doi: 10.1016/j.jpedsurg.2018.02.059. Epub 2018 Mar 4.