Prospective Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Generic Quality of Life Score
研究概览
简要总结
This is a prospective observational study of patients undergoing planned surgery for intestinal failure. The aims of the study are:
- To prospectively characterise preoperative bacterial populations amongst patients undergoing surgery for intestinal failure
- To examine the relationship between preoperative bacteriology and surgical site infection (SSI) in this patient group
- To investigate the effect of surgery and surgical site infection on generic and wound specific quality of life measures
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged >18 year
- •Diagnosis of intestinal failure or enterocutaneous fistula
- •Undergoing elective surgery within St Mark's hospital IF unit
排除标准
- •Unable or unwilling to provide informed consent
结局指标
主要结局
Change in Generic Quality of Life Score
时间窗: Baseline - 90 days
Generic health scores quantified by the validated EuroQoL 5 dimension, 5 level questionnaire (EQ5D-5L) at baseline, 30 and 90 days. (Minimum score 5, Maximum score 25)
Clinical Surgical Site Infection (SSI)
时间窗: 0-90 days
Classified as either superficial, deep or organ space as defined by the centre for disease control (CDC) classification 2021
Microbiological
时间窗: 0-90 days
Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples
Change in Wound Specific Quality of Life Score
时间窗: Baseline - 90 days
Quantified by the Wound-QoL questionnaire, a validated 17 item scale at baseline, 30 and 90 days (Minimum score 0, Maximum score 68)
Change in Decision Regret
时间窗: 30 and 90 days
Postoperative decision regret scores quantified by the decision regret scale (DRS) a validated 5 item questionnaire, at 30 and 90 days. (Minimum score 5, Maximum score 25)
Decision conflict
时间窗: Day 0
Preoperative decision conflict scores quantified by decision conflict scale (DCS), a validated 16 point scale (Minimum score 0, Maximum score 64)
次要结局
- Length of stay(from day of surgery (day 0))
- Complications(90 days)
- Abdominal wound healing(90 days)