Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis
NCT ID: NCT04213976
Last Updated: 2019-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2020-01-01
2020-12-31
Brief Summary
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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 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.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Ileostomy in continuity
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.
Ileostomy
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.
Conventional ileostomy
Paediatric patients having had a loop ileostomy as part of the treatment for a complex intestinal obstruction.
Ileostomy
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.
Interventions
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Ileostomy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients having been operated in one of the paediatric surgical department participating in this study.
Exclusion Criteria
* patient who had an ileostomy created in another center than the ones participating in the present study.
1 Minute
16 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Françoise Schmitt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Angers
Locations
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University Hospital of Brest
Brest, , France
University Hospital of Nantes
Nantes, , France
Necker Enfants Malades Hospital
Paris, , France
University Hospital of Rennes
Rennes, , France
University Hospital of Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Philine De Vries, MD, PhD
Role: primary
Sébastien Faraj, MD
Role: primary
Sabine Sarnacki, MD, PhD
Role: primary
Alexis Arnaud, MD, PhD
Role: primary
Itissam Kassite, MD
Role: primary
References
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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.
SANTULLI TV, BLANC WA. Congenital atresia of the intestine: pathogenesis and treatment. Ann Surg. 1961 Dec;154(6):939-48. No abstract available.
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.
Other Identifiers
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2019/10
Identifier Type: -
Identifier Source: org_study_id