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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04213976
Acronym
StomaPed
Enrollment
300
Registered
2019-12-30
Start date
2020-01-01
Completion date
2020-12-31
Last updated
2019-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enterocolitis, Necrotizing, Gastroschisis, Hirschsprung Disease, Intestinal Obstruction

Keywords

ileostomy, enteral nutrition, complications of stoma

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.

Interventions

PROCEDUREIleostomy

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.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Delay before full refunctionalization of the small intestinethrough study completion, an average of 6 monthsMean 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.

Secondary

MeasureTime frameDescription
Clinical description of the sub-groups of patients with ostomy in continuitythrough study completion, an average of 6 monthsClinical description of the patients (underlying disease, demographics, nutritional outcomes, medical and surgical complications) having had a Santulli or a Bishop-Koop ostomy.
Comparative analysis of the complications of ostomiesthrough study completion, an average of 6 monthsNumber and type of complications encountered after loop ileostomy and after ostomy in continuity
Subgroup analysis of the patients according to their underlying pathologythrough study completion, an average of 6 monthsComparative analysis of the efficacy and complication rates of the different types of stoma in subgroups of patients, according to their underlying pathology

Countries

France

Contacts

Primary ContactFrançoise Schmitt, MD, PhD
FrSchmitt@chu-angers.fr+33241354290

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026