SurgWeek-2: Identifying the Global Burden of Post Operative Complications: an International Prospective Cohort Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100,000
- 主要终点
- Global variation in post operative complications.
研究概览
简要总结
This study aims to assess and improve the global outcomes following surgery. Every year approximately 313 million operations are performed, with 50 million people experiencing a complication and unfortunately 3.5 million people will die following these operations. This study will assess how outcomes vary following surgery throughout the world and explore system access, quality and efficiency.
The secondary aims of this study are to (1) assess the use of antibiotics and the impact of resistant organisms globally, (2) assess who dies after an operation and whether there are factors that were identified that could have prevented the death, (3) assess the assess and outcomes to minimally invasive and robotic surgery, (4) assess the outcomes of the Bellwether procedures (laparotomy, caesarean delivery, open fracture management) as these are conditions used to assess the functioning of a health system.
The study will take place for six week in May-June 2026 and will aim to collect data from 100,000 patients across 1000 hospitals in 100 countries to give a global perspective on the above outcome measures. The data will be analysed by hospital income group to understand how resources impact on outcomes.
By combining global data on clinical outcomes with information on hospital resources, this study hopes to provide valuable insights into how to improve surgical care across diverse settings, making recommendations that lead to better access to safe, timely and affordable care for surgical problems worldwide.
详细描述
Background:
Surgery is a fundamental and core component of global healthcare. Without it we are unable to deliver safe maternity, trauma and cancer care. Access and treatment options vary globally. Approximately 313 million operations are performed globally every year, however high-quality outcome data is available for only a fraction of these. (1) There are estimated to be 50 million adults experiencing at least one post operative complication per year, of whom 3.5 million will die within 30 days of surgery. (1) Evidence suggests around half of complications are avoidable. (2, 3) Complications after surgery prolong inpatient admissions, increase care costs and can lead to death and disability. Global data on post-operative outcomes is lacking. We propose an International, prospective, multicentre cohort study to assess the global burden of post operative complications, its variation and sequalae.
Methodology:
This International, prospective, multicentre, global cohort study will include consecutive patients undergoing surgery within an overall six-week window between 4th May 2026 and 14th June 2026. The primary outcome will be complications measured by Clavien-Dindo grade at 30-days following surgery. Any hospital delivering surgery are eligible to participate. All patients undergoing elective or emergency operations will be included. Hospitals can have a team of up to three collaborators for each surgical speciality per week. Teams can choose to collect data for one or multiple specialities and one or multiple week periods. Hospitals can have multiple teams to allow all specialities to submit data. Data will be collected on consecutive patients from their chosen surgical specialities for one or multiple 7-day periods, with a subsequent 30-day follow-up over the six-week window. There will be no changes made to routine patient care pathways/management or follow-up as this will be an observational study. No identifiable data will be collected. There will be a mandatory site survey for all centres participating.
Appropriate registration and study approval as per local regulations is mandatory for participation. All data will be captured with REDCap - a secure online data management system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any operation (elective or emergency) performed in an operating theatre is eligible for inclusion, except for minor procedures specified in Appendix A.
- •All surgical specialties can participate including acute care surgery, breast surgery, cardiac surgery, colorectal surgery, general surgery, gynaecology, hepatobiliary surgery, neurosurgery, obstetrics, oesophagogastric surgery, ophthalmology, oral and maxillofacial surgery, orthopaedics, otolaryngology, paediatric surgery, plastic surgery, thoracic surgery, transplant surgery, trauma surgery, urology and vascular surgery.
- •Patients undergoing both day case surgery and inpatient surgery should be included.
排除标准
- •Patients who do not undergo an operation (e.g. planned operations that are cancelled).
- •Patients undergoing angiography or minor procedures.
- •Procedures performed outside of an operating theatre
- •Individual participating centres can choose to include children only, adults only, or both children and adults. If including children or adults only, an age cut off should be selected that is appropriate to the local context.
- •Each individual patient should only be included in the study once, based on the first operation they undergo within the data capture window. Therefore, patients who are re-operated within 30-days should only be entered once.
研究组 & 干预措施
Patients undergoing surgery
Patients undergoing surgery
结局指标
主要结局
Global variation in post operative complications.
时间窗: 30 days
The primary aim of SurgWeek-2 is to assess the global burden and variation of postoperative complications. We will determine the frequency of postoperative complications across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality.
次要结局
- 30-day Clavien-Dindo complication grade.(30 days)
- Global variation in postoperative infective complication and antimicrobial resistance rates.(30 days)
- Global variation in postoperative mortality rates and underlying reasons for postoperative mortality.(30 days)
- Global variation in access to and outcomes associated with minimally invasive and robotic surgery.(30 days)
- Global variation in the outcomes of the Bellwether procedures (laparotomy, caesarean delivery and open fracture management)(30 days)