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Colon or Colorectal ResectionSPREDNCT05523713

Development and Validation of a Predictive Score for Surgical Site Infections

A study testing Peripheral venous blood samples in people with Colon or Colorectal Resection and Partial or Total Gastrectomy, run by Hopital Foch at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Peripheral venous blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
283 participants
Where
4 sitesFrance
Study dates
6 Oct 2022to 27 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Current pregnancy or breastfeeding
  • Absence of affiliation to social security plan
  • Being deprived of liberty or under guardianship

Trial locations and contacts

4 sites in 1 country.

France4 sites
  • La pitiè Salpâtrière Hospital

    Paris

  • Saint Antoine Hospital

    Paris

  • Saint Joseph Hospital

    Paris

  • FOCH Hospital

    Suresnes

Other trials in France

About this study

Official title: Development and Validation of a Predictive Score for Surgical Site Infections (SSI): a Prospective Preoperative Trial in Major Digestive Surgery

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.

Read the 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.

Being tested
Peripheral venous blood samples

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peripheral venous blood samplesBiological

    10 ml in a sodium heparin tube and 5 ml in an EDTA tube

Study groups in NCT05523713
Study groupRoleWhat they receive
Patients with major elective digestive surgeryOtherThe 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).
Receives: Biological: Peripheral venous blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance of the preoperative prediction score for infectious complications of the surgical site.

    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.

    Measured: 30 days

Secondary outcomes (15)
  1. Performance of the postoperative prediction score for infectious complications of the surgical site.

    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.

    Measured: 30 days

  2. Performance of the preoperative prediction score for lung infections

    Defined by the prescription of antibiotics with one or more of the following elements: new or altered sputum, new or altered lung opacities on chest X-ray, fever > 38°C, leukocytes >12 × 109 /L.

    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.

    Measured: 30 days

  3. Performance of the preoperative prediction score for urinary tract infections

    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.

    Measured: 30 days

  4. Performance of the pre- and post-operative prediction score for the risk of post-operative septic shock

    Defined according to Sepsis-3 criteria: Sepsis-related Organ Failure Assessment score ≥ 2, persistent hypotension requiring vasopressors to maintain mean arterial pressure ≥ 65 mmHg and serum lactate > 2 mmol/L despite adequate volume resuscitation.

    The performance of the score will be evaluate based on the evaluation of 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.

    Measured: 30 days

  5. Performance of the pre- and post-operative prediction score for postoperative cardiovascular complications

    Defined as arrhythmia, cardiac arrest, acute coronary syndrome and acute heart failure.

    The performance of the score will be evaluate based on the evaluation of 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.

    Measured: 30 days

  6. Performance of the pre- and post-operative prediction score for the risk of postoperative deep vein thrombosis or pulmonary embolism.

    Confirmed by imaging (angioscanner for pulmonary embolism and echo-doppler for deep vein thrombosis).

    The performance of the score will be evaluate based on the evaluation of 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.

    Measured: 30 days

  7. Performance of the pre- and post-operative prediction score for the risk of post-operative acute renal failure.

    Defined by an increase of creatinine > 1.5 times of the baseline value or diuresis < 0.5 ml/kg/h for 6 to 12 hours.

    The performance of the score will be evaluate based on the evaluation of 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.

    Measured: 30 days

  8. Performance of the pre- and post-operative prediction score for the risk of acute bleeding, hematoma or postoperative anemia

    Requiring surgical intervention or blood transfusion.

    The performance of the score will be evaluate based on the evaluation of 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.

    Measured: 30 days

  9. Performance of the pre- and post-operative prediction score for the risk of postoperative occlusion or ileus.

    Defined as failure to resume transit within 72 hours of surgery.

    The performance of the score will be evaluate based on the evaluation of 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.

    Measured: 30 days

  10. Performance of the pre- and post-operative prediction score for the risk of postoperative delirium

    Defined as disturbed attention and disturbed consciousness, with cognitive impairment not explained by a pre-existing neurological pathology.

    The performance of the score will be evaluate based on the evaluation of 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.

    Measured: 30 days

  11. Performance of the pre- and post-operative prediction score for the overall severity of postoperative complications.

    Based on the Comprehensive Complication Index (CCI), with a severity threshold at CCI ≥ 20.

    The performance of the score will be evaluate based on the evaluation of 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.

    Measured: 30 days

  12. Intra-hospital mortality

    Assessed from patient medical records

    Measured: 30 days

  13. Length of hospital stay

    Assessed from patient medical records

    Measured: 30 days

  14. Cost of stay

    From Groupe Homogène de Séjours ( GHS) collected in the medical information departments (DIM) based on the Programme de médicalisation des systèmes d'information (PMSI) of each establishment.

    Measured: 30 days

  15. Score results

    The score is calculated using a machine learning method integrating immune, plasma protein and clinical data. The aim is to validate and generalize the score result (AUC = 0,94, p<10e-7) of a multivariate model already developed in a monocentric cohort of 43 patients undergoing major abdominal surgery (Stanford University).

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2022
  2. Study start6 Oct 2022
  3. Primary completion29 Nov 2023
  4. Study completion27 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
283 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05523713
Sponsor's protocol ID
2022-A01012-41
Acronym
SPRED
Status last verified
Mar 2025
First submitted
5 Aug 2022
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30229870
  • 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.

    PubMed 21817889
  • 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.

    PubMed 28816846
  • 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.

    PubMed 20643302
  • 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.

    PubMed 25253674

Questions about this trial

What is this clinical trial studying?

A study testing Peripheral venous blood samples in people with Colon or Colorectal Resection and Partial or Total Gastrectomy, run by Hopital Foch at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of the preoperative prediction score for infectious complications of the surgical site. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05523713, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

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