Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis

• Conditions: Intestinal Obstruction; Hirschsprung Disease; Gastroschisis; Enterocolitis, Necrotizing
• Interventions: Procedure: Ileostomy

• Registration Number: NCT04213976
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-27
• Last Update Submitted: 2019-12-27
• Study First Posted: 2019-12-30
• Last Update Posted: 2019-12-30
• Study Start: 2020-01-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional ileostomy	Ileostomy	Paediatric patients having had a loop ileostomy as part of the treatment for a complex intestinal obstruction.
Ileostomy in continuity	Ileostomy	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.

Primary Outcome Measures

Name	Time	Method
Delay before full refunctionalization of the small intestine	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

Name	Time	Method
Comparative analysis of the complications of ostomies	through study completion, an average of 6 months	Number and type of complications encountered after loop ileostomy and after ostomy in continuity
Clinical description of the sub-groups of patients with ostomy in continuity	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.
Subgroup analysis of the patients according to their underlying pathology	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

Trial Locations

Locations (5)

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