Helen Neilens, Victoria Allgar, Lexy Sorrell, Jade Chynoweth, Matthew Bailey, Paigan Aspinall, Angela King, Tracey Parkin, Andrew MacCormick, Somaiah Aroori
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Limited evidence suggests that a VLCD in patients with LS may result in better outcomes.</p><p><strong>Methods: </strong>This study aims to test the feasibility of delivering a multi-centre randomised clinical trial to compare a dietary intervention (VLCD plus motivational instructions) versus treatment as usual (TAU) in people with HS having LS. This study will provide high-quality data to estimate screening rates, recruitment, randomisation, retention, and intervention adherence. The study will also determine the definitive trial's most clinically relevant primary outcome. The study will also estimate resource use and costs associated with the delivery of the intervention. Seventy-two adults ≥ 18 who are scheduled to undergo elective LS and have a magnetic resonance imaging (MRI) identified HS will be recruited. Acceptability to the dietary intervention will be evaluated with food diaries and focus groups. Clinical and patient-reported outcomes will be collected at baseline, pre- and post-surgery, day of discharge, plus 30- and 90-day follow-up.</p><p><strong>Discussion: </strong>This feasibility study will provide data on the acceptability and feasibility of a dietary intervention for patients with HS having LS. The intervention has been developed based on scientific evidence from other clinical areas and patient experience; therefore, it is safe for this patient group. Patients with experience of LS and VLCDs have advised throughout the development of the study protocol. The findings will inform the design of a future definitive study.</p><p><strong>Trial registration: </strong>ISRCTN Number 19701345. Date registered: 20/03/2023. 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Furthermore, patients with HS are more likely to require a blood transfusion, which is associated with worse short and long-term outcomes. Patients with HS requiring LS receive no specific dietary treatment or advice. A very low-calorie diet (VLCD) is commonly used before gallbladder and bariatric surgery to reduce liver volumes and associated intraoperative morbidity. These diets typically provide 800-1200 kcal/day over a 2-4-week period. Limited evidence suggests that a VLCD in patients with LS may result in better outcomes.</p><p><strong>Methods: </strong>This study aims to test the feasibility of delivering a multi-centre randomised clinical trial to compare a dietary intervention (VLCD plus motivational instructions) versus treatment as usual (TAU) in people with HS having LS. This study will provide high-quality data to estimate screening rates, recruitment, randomisation, retention, and intervention adherence. The study will also determine the definitive trial's most clinically relevant primary outcome. The study will also estimate resource use and costs associated with the delivery of the intervention. Seventy-two adults ≥ 18 who are scheduled to undergo elective LS and have a magnetic resonance imaging (MRI) identified HS will be recruited. Acceptability to the dietary intervention will be evaluated with food diaries and focus groups. Clinical and patient-reported outcomes will be collected at baseline, pre- and post-surgery, day of discharge, plus 30- and 90-day follow-up.</p><p><strong>Discussion: </strong>This feasibility study will provide data on the acceptability and feasibility of a dietary intervention for patients with HS having LS. The intervention has been developed based on scientific evidence from other clinical areas and patient experience; therefore, it is safe for this patient group. 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引用次数: 0
摘要
背景：肝脏脂肪变性（HS）会增加肝脏手术（LS）的发病率和死亡率。此外，HS 患者更有可能需要输血，这与短期和长期预后较差有关。需要接受肝脏手术的 HS 患者没有接受特定的饮食治疗或建议。在进行胆囊手术和减肥手术之前，通常会使用极低热量饮食（VLCD）来减少肝脏体积和相关的术中发病率。这些饮食通常在 2-4 周内每天提供 800-1200 千卡热量。有限的证据表明，在 LS 患者中使用 VLCD 可能会获得更好的治疗效果：本研究旨在测试在患有 LS 的 HS 患者中开展多中心随机临床试验的可行性，以比较饮食干预（VLCD 加动机指导）与常规治疗（TAU）。这项研究将提供高质量的数据，以估算筛查率、招募、随机化、保留率和干预坚持率。该研究还将确定最终试验中与临床最相关的主要结果。该研究还将估算与实施干预相关的资源使用和成本。将招募 72 名年龄≥ 18 岁、计划接受选择性 LS 治疗且磁共振成像（MRI）确定为 HS 的成人。饮食干预的可接受性将通过饮食日记和焦点小组进行评估。将在基线、手术前后、出院当天以及 30 天和 90 天的随访中收集临床和患者报告结果：这项可行性研究将提供数据，说明对患有 LS 的 HS 患者进行饮食干预的可接受性和可行性。该干预措施是根据其他临床领域的科学证据和患者经验制定的，因此对该患者群体是安全的。在制定研究方案的整个过程中，具有 LS 和 VLCD 经验的患者提供了建议。研究结果将为未来明确研究的设计提供参考：ISRCTN 编号：19701345。注册日期：20/03/2023。URL: https://www.isrctn.com/ISRCTN19701345 。
Protocol for a feasibility multi-centre randomised controlled trial of a pre-operative two-week very low-calorie diet to reduce steatosis prior to liver resection (RESOLVE).
Background: Hepatic steatosis (HS) increases morbidity and mortality associated with liver surgery (LS). Furthermore, patients with HS are more likely to require a blood transfusion, which is associated with worse short and long-term outcomes. Patients with HS requiring LS receive no specific dietary treatment or advice. A very low-calorie diet (VLCD) is commonly used before gallbladder and bariatric surgery to reduce liver volumes and associated intraoperative morbidity. These diets typically provide 800-1200 kcal/day over a 2-4-week period. Limited evidence suggests that a VLCD in patients with LS may result in better outcomes.
Methods: This study aims to test the feasibility of delivering a multi-centre randomised clinical trial to compare a dietary intervention (VLCD plus motivational instructions) versus treatment as usual (TAU) in people with HS having LS. This study will provide high-quality data to estimate screening rates, recruitment, randomisation, retention, and intervention adherence. The study will also determine the definitive trial's most clinically relevant primary outcome. The study will also estimate resource use and costs associated with the delivery of the intervention. Seventy-two adults ≥ 18 who are scheduled to undergo elective LS and have a magnetic resonance imaging (MRI) identified HS will be recruited. Acceptability to the dietary intervention will be evaluated with food diaries and focus groups. Clinical and patient-reported outcomes will be collected at baseline, pre- and post-surgery, day of discharge, plus 30- and 90-day follow-up.
Discussion: This feasibility study will provide data on the acceptability and feasibility of a dietary intervention for patients with HS having LS. The intervention has been developed based on scientific evidence from other clinical areas and patient experience; therefore, it is safe for this patient group. Patients with experience of LS and VLCDs have advised throughout the development of the study protocol. The findings will inform the design of a future definitive study.
Trial registration: ISRCTN Number 19701345. Date registered: 20/03/2023. URL: https://www.isrctn.com/ISRCTN19701345 .
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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