Feasibility of a cluster randomised trial of a nutritional intervention to improve outcomes after cancer surgery in low-income countries

问题：对于许多类型的癌症，高质量的手术是唯一的治愈方法。在可能得不到化疗或放射治疗等治疗的低收入国家，情况尤其如此。手术顺利进行是很重要的。当并发症发生时，长期结果会更差，一些患者会死亡。越来越多的人认识到，在手术前促进患者的健康可以极大地提高手术成功的机会。当然，必须在手术和切除癌症的紧迫性和花时间改善患者健康的愿望之间取得平衡。癌症通常会导致极端的体重减轻，在许多国家，这是在先前存在的营养不良的基础上发生的。问题是：在手术前对患者进行营养补充剂强化治疗是否有益？来自高收入国家的研究表明，这是可能的，在低收入国家，好处可能更大。团队：我们是一个久负盛名的团队，致力于改善世界各地的外科治疗。来自低收入和中等收入国家的外科医生在研究中心得到支持，并制定自己的研究议程。癌症手术中的营养已被确定为一个高度优先的领域。我们的团队拥有完成这项工作所需的广泛技能。我们目前的工作：我们正在收集世界各地接受癌症手术的患者的数据。这是同类研究中规模最大的，目前正在100个国家进行。这些信息将使我们能够以一种以前不可能实现的方式，找出营养不良与手术结果之间的关系。但我们真正想做的是拿出一个解决方案。这项赠款申请是为了弥补我们目前的观察性研究和手术前治疗患者的试验之间的差距。我们拥有广泛的经验，目前正在启动猎鹰试验，寻找在低收入国家减少手术后伤口感染的步骤。未来拟议的试验：我们希望在低收入和中等收入国家进行一项大型研究，为接受癌症手术的患者提供营养补充剂(有时称为即食治疗性食品)。然后我们将衡量它是否会导致手术后更少的并发症和更好的结果。在我们能够做到这一点之前，我们需要做三件事。需要这笔启动资金：首先，我们需要找到一种在低收入国家筛查营养不良患者的好方法。这是为了确定哪些人可能从治疗中受益最多。人们可能会认为这将是容易和可靠的，但事实并非如此。需要开发或调整简单但准确的营养不良筛查方法，护士或医生可以为接受手术的患者使用这些方法。其次，我们需要找到合适的产品。这需要满足特定的营养要求，但必须是廉价、可持续的，而且最好是从当地获得。我们将与公司、专家、患者和临床医生合作，寻找最佳方案。第三，然后我们需要确保试验可以实际进行。我们将问一些务实的问题，比如，我们的合作医院是否有足够数量的患者可以参与？他们能接受营养补充剂吗？出院后，医院是否与患者保持联系，以确保我们知道他们会发生什么等情况？为了确保这类研究的成功，确定可行性和对所发现问题的计划至关重要。好处：我们建议在我们网络的一小部分地区(加纳、赞比亚、巴基斯坦和菲律宾)进行这项初步工作，但这项研究有望带来更大的好处。将重点放在手术前的健康和营养不良等问题上，将是改善全球癌症手术结果的关键。

THE PROBLEM: For many types of cancer, high quality surgery is the only cure. This is particularly true in low-income countries where treatments such as chemotherapy or radiotherapy may not be available. It is important that surgery goes well. When complications occur, longer term outcomes are worse, and some patients will die. It is increasingly recognised that boosting the health of patients before surgery can greatly improve the chances of success. Of course, a balance must be struck between the urgency to operate and remove the cancer and a desire to take time and improve a patient's health. Cancer often causes extreme weight loss and, in many countries, this occurs on top of pre-existing malnutrition. THE QUESTION: Would it be of benefit to intensively treat patients with nutritional supplements prior to surgery? Studies from high income countries suggest it could be, and the benefit may be even greater in low-income countries.THE TEAM: We are a well-established team working to improve surgical care worldwide. Surgeons from low- and middle-income countries are supported in Research Hubs and set their own research agenda. Nutrition in cancer surgery has been identified as an area of high priority. Our team has the broad set of skills required to make this work. OUR CURRENT WORK: We are gathering data on patients undergoing cancer surgery worldwide. It is the largest study of its kind and is taking place in 100 countries. This information will allow us to work out the relationship between malnutrition and the results of surgery in a way that hasn't been possible before. But what we really want to do is come up with a solution. This grant application is for funding to bridge the gap between our current observational study and a trial to treat patients prior to surgery. We have broad experience and are currently launching the FALCON trial, looking at steps to reduce wound infection after surgery in low-income countries. FUTURE PROPOSED TRIAL: We want to perform a large study in low- and middle-income countries giving a nutritional supplement (sometimes called ready-to-use therapeutic food) to patients undergoing cancer surgery. We will then measure whether it results in fewer complications and better outcomes after surgery. Before we can do that, we need to do three things. NEED FOR THIS PUMP PRIMING GRANT: First, we need to find a good way of screening patients for malnutrition in low-income countries. This is to identify those who may benefit most from a treatment. One would have thought that this would be easy and well-established, but it is not. Simple but accurate screening methods for malnutrition, which can be used by a nurse or a doctor for patients undergoing surgery, need to be developed or adapted. Second, we need to find an appropriate product. This needs to fulfil specific nutritional requirements but must be inexpensive, sustainable and ideally locally sourced. We will work with companies, experts, patients, and clinicians to find what is best. Third, we then need to make sure that a trial can actually be run. We will ask pragmatic questions such as, will there be a sufficient number of patients in our partner hospitals who can take part? Will they be able to take the nutritional supplement? Is the hospital in contact with patients after discharge to ensure we know what happens to them etc.? Determining the practicalities and planning for any problems identified is essential in ensuring the success of a study such as this.THE BENEFIT: We propose to perform this preliminary work in a small area of our network (Ghana, Zambia, Pakistan and the Philippines), but the research promises great benefits beyond this. Focusing on fitness prior to surgery and issues such as malnutrition will be essential in improving the outcomes of cancer surgery worldwide.