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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Conventional ileostomy | Paediatric patients having had a loop ileostomy as part of the treatment for a complex intestinal obstruction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Comparative analysis of the complications of ostomies |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Françoise Schmitt, MD, PhD | Contact | +33241354290 | FrSchmitt@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Françoise Schmitt, MD, PhD | University Hospital of Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Brest | Brest | 29200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13403593 | Result | 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. | |
| 14497096 | Result | SANTULLI TV, BLANC WA. Congenital atresia of the intestine: pathogenesis and treatment. Ann Surg. 1961 Dec;154(6):939-48. No abstract available. |
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| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D020139 | Gastroschisis |
| D020345 | Enterocolitis, Necrotizing |
| D006627 | Hirschsprung Disease |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009139 | Musculoskeletal Abnormalities |
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| ID | Term |
|---|---|
| D007081 | Ileostomy |
| ID | Term |
|---|---|
| D004766 | Enterostomy |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010030 | Ostomy |
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|
Number and type of complications encountered after loop ileostomy and after ostomy in continuity |
| through study completion, an average of 6 months |
| 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 |
| University Hospital of Nantes | Nantes | 44000 | France |
|
| Necker Enfants Malades Hospital | Paris | 75015 | France |
|
| University Hospital of Rennes | Rennes | 35200 | France |
|
| University Hospital of Tours | Tours | 37000 | France |
|
| 29602547 | 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. |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D004065 | Digestive System Abnormalities |
| D008531 | Megacolon |
| D003108 | Colonic Diseases |