Development and Validation of a Predictive Score for Surgical Site Infections (SSI): a Prospective Preoperative Trial in Major Digestive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 283
- 试验地点
- 4
- 主要终点
- Performance of the preoperative prediction score for infectious complications of the surgical site.
研究概览
简要总结
More than 8 millions surgical interventions are carried out each year in France. Postoperative complications, in particular infectious, can occur in 10 to 60% of cases and are the cause of postoperative revision in 30% of cases, an increase in mortality, length of stay, readmissions and lead to significant additional socio-economic costs. Currently, improvements in surgical practices have not reduced the incidence of surgical site complications. In this context, the development of predictive scores for the risk of post-operative complication becomes urgent in order to implement new interventions (pre-habilitation) or to modify surgical decisions (timing, approach) in order to reduce the risk of complications before surgery. Several recent studies highlights the importance of the immune response in postoperative prognosis. In particular, an imbalance between the adaptive and innate response involving MDSCs has been demonstrated in patients with postoperative complications.Thanks to new techniques for analyzing the immune system, in-depth analysis of the immune system before surgery is a very promising approach aimed at identifying predictive biomarkers of postoperative prognosis.
Our team has developed and patented a multivariate model integrating mass cytometry data, proteomics and clinical data collected before surgery to accurately predict the occurrence of a surgical site complication (AUC = 0.94, p<10e-7) in a monocentric cohort of 43 patients to major abdominal surgery (Stanford University).
The objective of the present study is to generalize and validate this preoperative predictive score of infectious complications of the surgical site in the 30 days following major digestive surgery on a larger workforce within a multicenter cohort and to validate this score at using a machine learning method.
详细描述
Research hypothesis and expected impact:
Postoperative complications are frequent and associated with excess mortality and increased costs for the health system. But, it is possible to avoid a significant number of these complications through prehabilitation programs, in particular to prepare patients at risk, and to reduce these postoperative events by 30%. However, it is currently not possible to predict, before surgery, which patients are at risk of developing a complication. Current predictive clinical scores such as the one developed by the American College of Surgeons are unsatisfactory (AUC = 68%).
This study will be a reference study to define the groups of patients at risk of complications in order to develop, in a second step, personalized patient pathways in order to optimize their health before surgery and thus improve post-operative results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included:
- •Aged 18 and over
- •Having undergone elective major digestive surgery:
- •Major surgery defined according to the recent recommendations of the European Surgical Association - PMID: 32172309 by a rate of infectious or cognitive complications between 20 and 30% according to the ACS risk calculator
- •Having expressed their non-opposition to participate in the study
- •Being affiliated to a French health insurance
排除标准
- •Patients with the following criteria will not be included:
- •Aged under 18
- •Having an ASA 4 or more, in palliative care
- •Having an expected duration of hospitalization < 24 hours
- •Not speaking French, illiterate patient
- •Having expressed their opposition to participate in the study
- •Current pregnancy or breastfeeding
- •Absence of affiliation to social security plan
- •Being deprived of liberty or under guardianship
研究组 & 干预措施
Patients with major elective digestive surgery
The size of the cohort is 300 patients
Population: Patients with major elective digestive surgery (eg, colon or colorectal resection, partial or total gastrectomy, pancreaticoduodenectomy, hepatectomy).
干预措施: Peripheral venous blood samples (Biological)
结局指标
主要结局
Performance of the preoperative prediction score for infectious complications of the surgical site.
时间窗: 30 days
Defined as superficial or deep surgical site infection and organ as defined by CDC 2021. The performance of the score will be evaluate based on the F1 score criterion and the AUROC. F1: score ranges from 0 to 1, where 0 is the worst and 1 is the best possible score. AUROC: score ranges from 0.5 to 1 where 1 is the best score and 0.5 means the model is as good as random.
次要结局
- Performance of the postoperative prediction score for infectious complications of the surgical site.(30 days)
- Performance of the preoperative prediction score for lung infections(30 days)
- Performance of the preoperative prediction score for urinary tract infections(30 days)
- Performance of the pre- and post-operative prediction score for the risk of post-operative septic shock(30 days)
- Performance of the pre- and post-operative prediction score for postoperative cardiovascular complications(30 days)
- Performance of the pre- and post-operative prediction score for the risk of postoperative deep vein thrombosis or pulmonary embolism.(30 days)
- Performance of the pre- and post-operative prediction score for the risk of post-operative acute renal failure.(30 days)
- Performance of the pre- and post-operative prediction score for the risk of acute bleeding, hematoma or postoperative anemia(30 days)
- Performance of the pre- and post-operative prediction score for the risk of postoperative occlusion or ileus.(30 days)
- Performance of the pre- and post-operative prediction score for the risk of postoperative delirium(30 days)
- Performance of the pre- and post-operative prediction score for the overall severity of postoperative complications.(30 days)
- Intra-hospital mortality(30 days)
- Length of hospital stay(30 days)
- Cost of stay(30 days)
- Score results(30 days)