A National Multi-centre Prospective Audit of Unplanned Surgical and Endoscopic Interventions in Patients Who Have Undergone Bariatric Surgery in the UK or Abroad
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 30-day mortality
研究概览
简要总结
The goal of this observational study is to investigate the incidence, management, and outcomes of complications following bariatric surgery in patients in the United Kingdom. The main questions it aims to answer are:
- What is the prevalence of unplanned interventions due to complications following bariatric surgery in the UK?
- What are the current practices for managing these complications, and how do they impact patient outcomes?
Participants will:
Be identified from hospitals treating patients presenting with complications following bariatric surgery.
Have their data collected regarding demographics, surgical history, complications, treatments, and outcomes.
Researchers will compare different management strategies and their impact on patient outcomes, with the aim of identifying best practices to improve emergency bariatric care and factors leading to patients attending as an emergency.
详细描述
The National Emergency Bariatric Surgery Audit (NEBSA) is an observational study aimed at investigating the incidence, management, and outcomes of complications following bariatric surgery in the United Kingdom. The detailed description of the protocol includes the following components:
Patient Recruitment and Data Collection:
Patients will be identified in hospitals across the UK where they present for an unplanned intervention to treat a complication related to or following bariatric surgery.
Data on demographics, surgical history, site and type of index bariatric surgery, comorbidities, complications, treatments, and outcomes will be collected through a combination of electronic health records and manual data extraction.
Quality Assurance Plan:
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
- •Admissions from i) the emergency department, clinic, urgent care or primary care to the bariatric surgical team as an emergency; ii) from an inpatient team as an urgent referral; iii) a return to theatre following an elective bariatric procedure; iv) another hospital via patient transfer to a specialised unit.
- •Participants undergoing any intervention or procedure to treat or diagnose bariatric complications, (e.g., OGDs, interventional radiology, surgery, supplemental enteral or parenteral nutrition).
排除标准
- •age <18 years old
- •have a length of stay <24 hrs.
- •initial diagnosis of BSE is changed or if their readmission is found to be unrelated to previous bariatric surgery.
结局指标
主要结局
30-day mortality
时间窗: up to 30 days from procedure or admission
Time in days
Inpatient length of stay
时间窗: Up to 100 weeks from admission
Time in days
Clavien-Dindo Classification of Complications
时间窗: through study completion, an average of 1 year
Severity of complication
次要结局
- Frequency and rate of nutritional support(through study completion, an average of 1 year)
- Frequency and type of interventional radiology(through study completion, an average of 1 year)
- Frequency and type of surgery, diagnostic or therapeutic procedures(through study completion, an average of 15 years post-op from index surgery)
- Frequency of admission to critical care units(through study completion, an average of 1 year)
- Engagement with NHS specialised weight management services(through study completion, an average of 10 years prior to admission)
- Site and time of index bariatric surgery(Time from index surgery to admission)
研究者
Mohamed Aly
Consultant Upper GI and General Surgeon
Bedfordshire Hospitals NHS Foundation Trust