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Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis (StomaPed)

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ClinicalTrials.gov Identifier: NCT04213976
Recruitment Status : Not yet recruiting
First Posted : December 30, 2019
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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.


Condition or disease Intervention/treatment
Intestinal Obstruction Gastroschisis Enterocolitis, Necrotizing Hirschsprung Disease Procedure: Ileostomy

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Ostomy in Continuity or Conventional Ileostomy for Complex Pediatric Intestinal Diseases: a Retrospective Multicentric Analysis
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020


Group/Cohort Intervention/treatment
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.
Procedure: 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 Names:
  • Loop ileostomy
  • Santulli ileostomy
  • Bishop-Koop ileostomy

Conventional ileostomy
Paediatric patients having had a loop ileostomy as part of the treatment for a complex intestinal obstruction.
Procedure: 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 Names:
  • Loop ileostomy
  • Santulli ileostomy
  • Bishop-Koop ileostomy




Primary Outcome Measures :
  1. Delay before full refunctionalization of the small intestine [ Time Frame: through study completion, an average of 6 months ]
    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.


Secondary Outcome Measures :
  1. Clinical description of the sub-groups of patients with ostomy in continuity [ Time Frame: through study completion, an average of 6 months ]
    Clinical description of the patients (underlying disease, demographics, nutritional outcomes, medical and surgical complications) having had a Santulli or a Bishop-Koop ostomy.

  2. Comparative analysis of the complications of ostomies [ Time Frame: through study completion, an average of 6 months ]
    Number and type of complications encountered after loop ileostomy and after ostomy in continuity

  3. Subgroup analysis of the patients according to their underlying pathology [ Time Frame: through study completion, an average of 6 months ]
    Comparative analysis of the efficacy and complication rates of the different types of stoma in subgroups of patients, according to their underlying pathology



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213976


Contacts
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Contact: Françoise Schmitt, MD, PhD +33241354290 FrSchmitt@chu-angers.fr

Locations
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France
University Hospital of Brest
Brest, France, 29200
Contact: Philine De Vries, MD, PhD       philine.devries@chu-brest.fr   
University Hospital of Nantes
Nantes, France, 44000
Contact: Sébastien Faraj, MD       sebastien.faraj@chu-nantes.fr   
Necker Enfants Malades Hospital
Paris, France, 75015
Contact: Sabine Sarnacki, MD, PhD       sabine.sarnacki@aphp.fr   
University Hospital of Rennes
Rennes, France, 35200
Contact: Alexis Arnaud, MD, PhD       alexis.arnaud@chu-rennes.fr   
University Hospital of Tours
Tours, France, 37000
Contact: Itissam Kassite, MD       ibtissam.kassite@univ-tours.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Françoise Schmitt, MD, PhD University Hospital of Angers
Publications of Results:
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04213976    
Other Study ID Numbers: 2019/10
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
ileostomy
enteral nutrition
complications of stoma
Additional relevant MeSH terms:
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Gastroschisis
Enterocolitis
Hirschsprung Disease
Intestinal Obstruction
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Digestive System Abnormalities
Megacolon
Colonic Diseases
Congenital Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical