Development grant for a multicentre, randomised trial to reduce surgical site infection following emergency gastrointestinal surgery in LMICs

为一项多中心、随机试验提供开发资助，以减少中低收入国家紧急胃肠手术后手术部位感染

• 批准号: MR/N029984/1
• 负责人: Aneel Bhangu
• 金额: $ 16.17万
• 依托单位: University of Birmingham
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2016
• 资助国家: 英国
• 起止时间: 2016 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FN029984%2F1
• 关键词: Development; grant; multicentre; randomised; trial

THE PROBLEM: Infections in wounds after bowel surgery are common in all countries. They have adverse effects for patients, doctors and health systems. For patients, they are painful, smelly, reduce quality of life and reduce time taken to return to normal activities. They are hard to treat and require prescriptions of long courses of antibiotics and return trips to the operating theatre, increasing antibiotic resistance and reducing future available treatments. They are extremely costly and require long lengths of stay in hospital and lots of nursing time. In low and middle-income countries, they are at least twice as common as they are in high-income countries. Rates of antibiotic resistance are also higher, meaning they are even harder to treat. Wound infections affect both adults and children and since people of working age can't return quickly to work, their families and communities are also adversely affected.FUTURE PROPOSED TRIAL: We aim to perform a large, multi-country randomised controlled trial looking at two simple interventions to reduce wound infections after emergency bowel surgery. Emergency surgery is the most common, demanding and burdensome type of bowel surgery in low and middle income countries (LMICs). Since the burden of wound infections is highest in these countries compared to other places in the world, this research proposal if timely and focussed toward a clinical need in LMICs. Wound infections are complex and testing two interventions at the same time may show even greater effect than just testing one, and it also improves value for money. The trial will be large and require around 2000 patients.NEED FOR A DEVELOPMENT GRANT: Before we can submit a highly competitive, world-class grant proposal, we need to perform some development work to ensure that we are prepared. This work will develop a final, tangible plan for that application, and engage local doctors and research staff into the process. We aim to:1. Hold on site meetings in participating countries, led by local surgeons, to engage a range of staff and shortlist interventions which could be tested in their units.2. Deliver on-site research skills training that will increase local research capacity and leadership.3. Perform small observational studies to ensure that sites have a strategy to follow-up patients during the main trial.4. Hold our first face-to-face collaborator group meeting, to develop a finalised protocol based on the selected interventions, that can be used for a main trial application. This meeting will also allow us to foster the strongest possible relationships between our new collaborative and improve team working.NEED FOR MORE SURGICAL RESEARCH: There is a lack of surgical research across the world, partly driven by a lack of doctors regularly performing surgical research. This initial proposal will allow is to form a collaborative that could last for many decades. We predict that this network will enable us to deliver more trials into the future, of larger sizes and complexity. In the UK, we have developed hub and spoke research networks to deliver similar trials. We aim to transfer these research skills from the NHS to LMICs to help disseminate best surgical research practice widely. This will also speed recruitment to trials and maximise generalizability. We aim that this development grant and subsequent main grant will produce a generation of surgical researchers focused on testing cost-effective interventions internationally.

问题：肠道手术后伤口感染在所有国家都很常见。它们对患者、医生和卫生系统都有不利影响。对于患者来说，疼痛、发臭、降低生活质量、减少恢复正常活动所需的时间。它们很难治疗，需要开长疗程的抗生素处方，还需要往返手术室，这增加了抗生素耐药性，减少了未来可用的治疗方法。它们非常昂贵，需要长时间的住院治疗和大量的护理时间。在低收入和中等收入国家，此类疾病的发生率至少是高收入国家的两倍。抗生素耐药率也更高，这意味着它们更难治疗。伤口感染对成人和儿童都有影响，由于工作年龄的人无法迅速重返工作岗位，他们的家庭和社区也受到不利影响。未来建议的试验：我们的目标是进行一项大型、多国随机对照试验，研究两种简单的干预措施以减少紧急肠手术后伤口感染。在低收入和中等收入国家（LMICs），急诊手术是最常见、要求最高和负担最重的肠道手术。由于与世界上其他地方相比，这些国家的伤口感染负担最高，因此这项研究建议是及时的，并侧重于中低收入国家的临床需求。伤口感染是复杂的，同时测试两种干预措施可能比只测试一种干预措施效果更好，而且还能提高成本效益。这项试验规模很大，需要约2000名患者。对发展奖助金的需求：在我们能够提交一份极具竞争力、世界级的奖助金提案之前，我们需要进行一些发展工作，以确保我们做好了准备。这项工作将为这一应用制定一个最终的、切实可行的计划，并让当地医生和研究人员参与这一过程。我们的目标是：1；在参与国举行由当地外科医生领导的现场会议，让一系列工作人员参与，并列出可在其单位进行测试的干预措施。提供现场研究技能培训，提高当地的研究能力和领导能力。进行小型观察性研究，以确保各试验点在主要试验期间有随访患者的策略。举行我们的第一次面对面合作小组会议，根据选定的干预措施制定可用于主要试验应用的最终方案。这次会议还将使我们能够在新的协作和改进团队工作之间建立最牢固的关系。需要更多的外科研究：全世界都缺乏外科研究，部分原因是缺乏定期进行外科研究的医生。这个最初的提议将使我们形成一个可以持续几十年的合作关系。我们预测，这个网络将使我们能够在未来进行更多规模更大、更复杂的试验。在英国，我们已经开发了中心和辐状研究网络来进行类似的试验。我们的目标是将这些研究技能从NHS转移到中低收入国家，以帮助广泛传播最佳外科研究实践。这也将加快招聘进入试验阶段，并最大限度地扩大推广范围。我们的目标是，这项发展资助和随后的主要资助将培养一代外科研究人员，专注于在国际上测试具有成本效益的干预措施。

项目成果

[GlobalSurg 1's participation from Peru and new challenges for GlobalSurg 2: epidemiology of surgical site infection].

[GlobalSurg 1秘鲁的参与以及GlobalSurg 2的新挑战：手术部位感染的流行病学]。

• 发表时间: 2016
• 期刊: organo oficial de la Sociedad de Gastroenterologia del Peru
• 作者: Bendezú-Quispe G

Determinants of morbidity and mortality following emergency abdominal surgery in children in low-income and middle-income countries.

• DOI: 10.1136/bmjgh-2016-000091
• 发表时间: 2016
• 期刊: BMJ global health
• 影响因子: 8.1
• 作者: GlobalSurg Collaborative

A multicentre evaluation of emergency abdominal surgery in South Africa: Results from the GlobalSurg-1 South Africa study.

南非紧急腹部手术的多中心评估：GlobalSurg-1 南非研究的结果。

• DOI: 10.7196/samj.2016.v106i2.10183
• 发表时间: 2016
• 期刊: South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde
• 作者: Spence RT