SurgPASS: Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Training and checklist completion
研究概览
简要总结
SurgPASS is a pilot randomised cluster trial utilising a pre-operative checklist with the aim of reducing deaths after surgery. If SurgPASS is successful, the intervention will be implemented in a separate full-scale cluster randomised trial.
详细描述
Title: Reducing deaths after surgery in low- and middle-income countries: A pilot cluster randomised trial
Aim: This pilot randomised cluster trial aims to evaluate the feasibility of a large-scale cluster randomised trial to assess the effectiveness and implementation of a pre-operative checklist to reduce deaths after surgery. If this pilot study is successful, we aim to assess the intervention in a separate full-scale cluster randomised trial.
- Objective 1: To determine feasibility and fidelity of delivering the intervention.
- Objective 2: To determine the rate recruitment to inform how long it will take to recruit to a future cluster randomised trial.
- Objective 3: To obtain information on postoperative outcomes to help inform the outcomes used and sample size of the future cluster randomised trial.
Design: Pilot cluster randomised trial.
Inclusion: Adult (>18 years old) non-pregnant patients undergoing emergency abdominal surgery with an incision of ≥5cm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Given this is a cluster trial, blinding of participants are not relevant as the entire cluster will be randomised to either the intervention or usual care.
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
- •Patients undergoing emergency major abdominal surgery (i.e., midline or non-midline) with an incision greater than or equal to 5cm
- •Patient must not be pregnant
- •Adults only (greater than or equal to 18 years old)
排除标准
- •Minimally invasive surgery
- •Surgery for appendicitis
研究组 & 干预措施
Intervention - Surgpass checklist and training champions
A preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions.
干预措施: SurgPASS - intervention (Other)
Comparator - usual care
Usual care as per local practice at that site.
结局指标
主要结局
Training and checklist completion
时间窗: Within 30 days postoperatively
Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)
次要结局
未报告次要终点