Clinical trial NCT05523713: Development and Validation of a Predictive Score for Surgical Site Infections
Official title: Development and Validation of a Predictive Score for Surgical Site Infections (SSI): a Prospective Preoperative Trial in Major Digestive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon or Colorectal Resection
Partial or Total Gastrectomy
Pancreaticoduodenectomy
Hepatectomy
Lead sponsor: Hopital Foch
Sponsor class: OTHER
Collaborators: name: surge2surgery
First posted: 2022-08-31
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Performance of the preoperative prediction score for infectious complications of the surgical site.
timeFrame: 30 days
Secondary outcomes:
measure: Performance of the postoperative prediction score for infectious complications of the surgical site.
timeFrame: 30 days
measure: Performance of the preoperative prediction score for lung infections
timeFrame: 30 days
measure: Performance of the preoperative prediction score for urinary tract infections
timeFrame: 30 days
measure: Performance of the pre- and post-operative prediction score for the risk of post-operative septic shock
timeFrame: 30 days
measure: Performance of the pre- and post-operative prediction score for postoperative cardiovascular complications
timeFrame: 30 days
measure: Performance of the pre- and post-operative prediction score for the risk of postoperative deep vein thrombosis or pulmonary embolism.
timeFrame: 30 days
measure: Performance of the pre- and post-operative prediction score for the risk of post-operative acute renal failure.
timeFrame: 30 days
measure: Performance of the pre- and post-operative prediction score for the risk of acute bleeding, hematoma or postoperative anemia
timeFrame: 30 days
measure: Performance of the pre- and post-operative prediction score for the risk of postoperative occlusion or ileus.
timeFrame: 30 days
measure: Performance of the pre- and post-operative prediction score for the risk of postoperative delirium
timeFrame: 30 days
measure: Performance of the pre- and post-operative prediction score for the overall severity of postoperative complications.
timeFrame: 30 days
measure: Intra-hospital mortality
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Cost of stay
timeFrame: 30 days
measure: Score results
timeFrame: 30 days
Other outcomes:
measure: Performance of the global model
timeFrame: 30 days
Locations:
city: Paris
country: France
facility: La pitiè Salpâtrière Hospital
city: Paris
country: France
facility: Saint Antoine Hospital
city: Paris
country: France
facility: Saint Joseph Hospital
city: Suresnes
country: France
facility: FOCH Hospital
Study officials:
References:
citation: Storesund A, Haugen AS, Hjortas M, Nortvedt MW, Flaatten H, Eide GE, Boermeester MA, Sevdalis N, Softeland E. Accuracy of surgical complication rate estimation using ICD-10 codes. Br J Surg. 2019 Feb;106(3):236-244. doi: 10.1002/bjs.10985. Epub 2018 Sep 18.
citation: Hawn MT, Vick CC, Richman J, Holman W, Deierhoi RJ, Graham LA, Henderson WG, Itani KM. Surgical site infection prevention: time to move beyond the surgical care improvement program. Ann Surg. 2011 Sep;254(3):494-9; discussion 499-501. doi: 10.1097/SLA.0b013e31822c6929.
citation: Gaudilliere B, Angst MS, Hotchkiss RS. Deep Immune Profiling in Trauma and Sepsis: Flow Is the Way to Go! Crit Care Med. 2017 Sep;45(9):1577-1578. doi: 10.1097/CCM.0000000000002594. No abstract available.
citation: Zhu X, Herrera G, Ochoa JB. Immunosupression and infection after major surgery: a nutritional deficiency. Crit Care Clin. 2010 Jul;26(3):491-500, ix. doi: 10.1016/j.ccc.2010.04.004.
citation: Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.