Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis

NCT04213976 | Unknown

• 1 other identifier: 2019/10
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Intestinal Obstruction; Gastroschisis; Enterocolitis, Necrotizing; Hirschsprung Disease

Keywords

ileostomy; enteral nutrition; complications of stoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical description of the sub-groups of patients with ostomy in continuity

  through study completion, an average of 6 months

• Comparative analysis of the complications of ostomies

  through study completion, an average of 6 months

• Subgroup analysis of the patients according to their underlying pathology

  through study completion, an average of 6 months

Study Arms (2)

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

Conventional ileostomy

Paediatric patients having had a loop ileostomy as part of the treatment for a complex intestinal obstruction.

Procedure: Ileostomy

Interventions

Ileostomy PROCEDURE

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.

Also known as: Loop ileostomy, Santulli ileostomy, Bishop-Koop ileostomy

Conventional ileostomy; Ileostomy in continuity

Eligibility Criteria

• Age: 1 Minute - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (5)

University Hospital of Brest

Brest, 29200, France

Location

University Hospital of Nantes

Nantes, 44000, France

Location

Necker Enfants Malades Hospital

Paris, 75015, France

Location

University Hospital of Rennes

Rennes, 35200, France

Location

University Hospital of Tours

Tours, 37000, France

Location

Related Publications (3)

• 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.

  PMID: 13403593 RESULT

• SANTULLI TV, BLANC WA. Congenital atresia of the intestine: pathogenesis and treatment. Ann Surg. 1961 Dec;154(6):939-48. No abstract available.

  PMID: 14497096 RESULT

• 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.

  PMID: 29602547 RESULT

MeSH Terms

Conditions

Intestinal Obstruction; Gastroschisis; Enterocolitis, Necrotizing; Hirschsprung Disease

Interventions

Ileostomy

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Digestive System Abnormalities; Megacolon; Colonic Diseases

Intervention Hierarchy (Ancestors)

Enterostomy; Digestive System Surgical Procedures; Surgical Procedures, Operative; Ostomy

Study Officials

• Françoise Schmitt, MD, PhD

  University Hospital of Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Françoise Schmitt, MD, PhD

CONTACT

+33241354290; FrSchmitt@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 30, 2019
• Study Start: January 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

FR (5)