Incidence and Risk Factors of Parastomal Bulging in Patients With Ileostomy or Colostomy: a Register-based Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,019
- 主要终点
- Number of patients with the incidence of parastomal bulging
研究概览
简要总结
The purpose of this study is to use routinely-collected health data from registers to examine the incidence of parastomal bulging (PB) at different time points in the first year after surgery for ileostomy or colostomy. Additionally, the purpose is to investigate risk factors for development of PB.
详细描述
Parastomal bulging (PB) in patients with ileostomy and colostomy in the Capital Region of Denmark up to one year after surgery is the primary outcome in this study. The investigators will use a register-based study design to evaluate routinely-collected health data from the Danish Stoma Database Capital Region (DSDCR). Incidence of PB one year post surgery and at different points of follow-up during the first year will be investigated using survival analysis. Potential risk factors will be investigated controlling for potential confounders. In order to include relevant variables on lifestyle, comorbidity, and physical status, data from the DSDCR will be linked to data from the Danish Anaesthesia Database.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is registered in the Danish Stoma Database Capital Region
- •Is registered as having either ileostomy, jejunostomy, sigmoidostomy, or transversostomy
排除标准
- •Patients with urostomy or unknown stoma type
结局指标
主要结局
Number of patients with the incidence of parastomal bulging
时间窗: Up to 1 year after primary surgery
Parastomal bulging evaluated by stoma care nurses through symptoms, visual inspection, and stomal exploration. Parastomal bulging is evaluated at scheduled visits at stoma care clinics on postoperative days 30, 90, 180, and 365, and at any additional visits inbetween.
次要结局
未报告次要终点
研究者
Rune Martens Andersen
PhD fellow
Rigshospitalet, Denmark