Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis

Hirschsprung Disease Clinical Trial

— StomaPed  

Official title:

Ostomy in Continuity or Conventional Ileostomy for Complex Pediatric Intestinal Diseases: a Retrospective Multicentric Analysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04213976
• Other study ID #: 2019/10
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2019
• Source: University Hospital, Angers
• Contact: Françoise Schmitt, MD, PhD
• Phone: +33241354290
• Email: FrSchmitt[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Gastroschisis
• Hirschsprung Disease
• Intestinal Obstruction

Intervention

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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & 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. — View Citation

SANTULLI TV, BLANC WA. Congenital atresia of the intestine: pathogenesis and treatment. Ann Surg. 1961 Dec;154:939-48. — View 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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical description of the sub-groups of patients with ostomy in continuity	Clinical description of the patients (underlying disease, demographics, nutritional outcomes, medical and surgical complications) having had a Santulli or a Bishop-Koop ostomy.	through study completion, an average of 6 months
Secondary	Comparative analysis of the complications of ostomies	Number and type of complications encountered after loop ileostomy and after ostomy in continuity	through study completion, an average of 6 months
Secondary	Subgroup analysis of the patients according to their underlying pathology	Comparative analysis of the efficacy and complication rates of the different types of stoma in subgroups of patients, according to their underlying pathology	through study completion, an average of 6 months