Ostomy in Continuity or Conventional Ileostomy for Complex Pediatric Intestinal Diseases: a Retrospective Multicentric Analysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Delay before full refunctionalization of the small intestine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Minute 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/
- •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.
排除标准
- •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.
结局指标
主要结局
Delay before full refunctionalization of the small intestine
时间窗: 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.
次要结局
- Comparative analysis of the complications of ostomies(through study completion, an average of 6 months)
- Clinical description of the sub-groups of patients with ostomy in continuity(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)