School of Medical, Veterinary & Life Sciences (MVLS), University of Glasgow, Glasgow, UK.
Department of General Surgery, Royal Alexandra Hospital, NHS Greater Glasgow and Clyde, Corsebar Road, Paisley, PA2 9PN, UK.
BMC Surg. 2023 Jul 5;23(1):190. doi: 10.1186/s12893-023-02093-5.
Emergency laparotomy (EmLAP) is one of the commonest emergency operations performed in the United Kingdom (approximately 30, 000 laparotomies annually). These potentially high-risk procedures can be life changing with frail patients and/ or older adults (≥ 65 years) having the poorest outcomes, including mortality. There is no gold standard of frailty assessment and no clinical chemical biomarkers existing in practice. Early detection of subclinical changes or deficits at the molecular level are essential in improving our understanding of the biology of frailty and ultimately improving patient outcomes. This study aims primarily to compare preoperative frailty markers, including a blood-based biomarker panel, in their ability to predict 30 and 90-day mortality post-EmLAP. The secondary aim is to analyse the influence of perioperative frailty on morbidity and quality of life post-EmLAP.
A prospective single centred observational study will be conducted on 150 patients ≥ 40 years of age that undergo EmLAP. Patients will be included according to the established NELA (National Emergency Laparotomy Audit) criteria. The variables collected include demographics, co-morbidities, polypharmacy, place of residence, indication and type of surgery (as per NELA criteria) and prognostic NELA score. Frailty will be assessed using: a blood sample for ultra-high performance liquid chromatography mass spectrometry analysis; preoperative CT abdomen pelvis (sarcopenia) and Rockwood Clinical Frailty Scale (CFS). Patients will be followed up for 90 days. Variables collected include blood samples (at post operative day 1, 7, 30 and 90), place of residence on discharge, morbidity, mortality and quality of life (EQ-5D-5 L). The frailty markers will be compared between groups of frail (CFS ≥ 4) and non-frail using statistical methods such as regression model and adjusted for appropriate confounding factors.
This study hypothesises that frailty level changes following EmLAP in frail and non- frail patients, irrespective of age. We propose that non- frail patients will have better survival rates and report better quality of life compared to the frail. By studying the changes in metabolites/ biomarkers in these patients and correlate them to frailty status pre-surgery, this highly novel approach will develop new knowledge of frailty and define a new area of clinical biomolecular research.
ClinicalTrials.gov: NCT05416047. Registered on 13/06/2022 (retrospectively registered).
急诊剖腹手术（EmLAP）是英国最常见的急诊手术之一（每年约进行 30000 例剖腹手术）。这些潜在高风险的手术可能会改变患者的生活，体弱患者和/或老年人（≥65 岁）的预后最差，包括死亡率。目前还没有评估脆弱性的金标准，也没有临床化学生物标志物。在改善对脆弱性生物学的理解并最终改善患者预后方面，早期发现分子水平的亚临床变化或缺陷至关重要。本研究的主要目的是比较术前脆弱性标志物，包括基于血液的生物标志物组，以预测 EmLAP 术后 30 天和 90 天的死亡率。次要目的是分析围手术期脆弱性对 EmLAP 术后发病率和生活质量的影响。
将对 150 名年龄≥40 岁的接受 EmLAP 的患者进行前瞻性单中心观察性研究。将根据既定的 NELA（国家急诊剖腹手术审计）标准纳入患者。收集的变量包括人口统计学特征、合并症、多药治疗、居住地、手术指征和类型（根据 NELA 标准）以及预后 NELA 评分。将使用以下方法评估脆弱性：进行超高性能液相色谱-质谱分析的血液样本；术前腹部骨盆 CT（肌少症）和 Rockwood 临床脆弱性量表（CFS）。将对患者进行 90 天的随访。收集的变量包括血液样本（术后第 1、7、30 和 90 天）、出院时的居住地、发病率、死亡率和生活质量（EQ-5D-5 L）。使用回归模型等统计方法比较脆弱组（CFS≥4）和非脆弱组之间的脆弱性标志物，并针对适当的混杂因素进行调整。
本研究假设，无论年龄大小，EmLAP 后脆弱患者和非脆弱患者的脆弱程度都会发生变化。我们提出，与脆弱患者相比，非脆弱患者的生存率更高，生活质量报告更好。通过研究这些患者的代谢物/生物标志物的变化，并将其与术前的脆弱状态相关联，这种极具创新性的方法将为脆弱性研究开辟新的知识领域，并定义临床生物分子研究的一个新领域。
ClinicalTrials.gov：NCT05416047。于 2022 年 6 月 13 日注册（追溯注册）。
